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  1. Mobile Medical Applications

Examples of Pre-Market Submissions that Include MMAs Cleared or Approved by FDA

The following is a list of some of the mobile medical applications that the FDA has cleared or approved since 1997. For more information about any of the apps below, please search either the FDA 510(k) medical devices database by 510(k) number or the PMA database by PMA number.

FDA Cleared Mobile Medical Applications
Last updated (July 25, 2018)

Device Name Applicant 510(k) or PMA number Clearance Date Product Code Product Code Description Regulation Regulation Description
ISage Rx (ISage Rx Basal Insulin Titration) ISag Rx, Inc. K161865 3/7/2017 NDC Calculator, Drug Dose 868.1890 Predictive pulmonary-function value calculator.
DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM, INC. P120005/S050 3/8/2017 MDS Sensor, Glucose, Invasive    
My Dose Coach Sanofi, Inc. K163099 3/22/2017 NDC Calculator, Drug Dose 868.1890 Predictive pulmonary-function value calculator.
GoSpiro MONITORED THERAPEUTICS, INC. K163249 3/24/2017 BZG Spirometer, Diagnostic 868.1840 Diagnostic spirometer.
LISA Siemens Medical Solutions USA, Inc. K163297 3/24/2017 JAK System, X-Ray, Tomography, Computed 892.1750 Computed tomography x-ray system.
BewellConnect® MyTensio Bluetooth blood pressure monitor Shenzhen Kingyield Technology Co., Ltd K161530 3/31/2017 DXN system, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
Move Forward 3D Motion Simulation Service Biomet Orthopedics K162559 3/31/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
eRAD PACS and eRAD RIS/PACS eRAD, Inc., K161341 4/5/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
Smart Dongle Blood Glucose Monitoring System TaiDoc Technology Corporation K162382 4/14/2017 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
Cliniview Palodex Group Oy K162799 4/25/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
Gauss Surgical Triton Sponge System Gauss Surgical, Inc. K163507 4/25/2017 PBZ Image Processing Device For Estimation Of External Blood Loss 880.2750 (no description)
NuVasive® NuvaLine™ Mobile App NuVasive, Incorporated K162647 5/1/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
A&D Engineering, Inc. A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor K163683 5/3/2017 DXN system, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
Picture Archibing & Communications System (PACS) NucleusHealth, LLC K171130 5/4/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
SurgiCase Viewer Materialise N.V. K170419 5/11/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
A&D Engineering, Inc. A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor K170196 5/17/2017 DXN system, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
Scientific Intake Sensor Monitored Alimentary Restriction Therapy (“SmartByte”) Device K171165 5/18/2017 ONY Oral Removable Retainer For Weight Management 876.5981 A removable oral device used during meals to limit food intake.
Eko Devices, Inc. Eko Model E5 (EME5) K170874 5/19/2017 DQD Stethoscope, electronic 870.1875 Stethoscope
DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM, INC. P120005/S059 5/22/2017 MDS Sensor, Glucose, Invasive    
Skylit Phototherapy System Skylit Medical K170489 5/23/2017 FTC Light, Ultraviolet, Dermatological 878.4630 Ultraviolet lamp for dermatologic disorders.
Etiometry, Inc. T3 Software K163065 5/26/2017 PLB Multivariate Vital Signs Index 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
Sanofi Aventis US LLC. My Dose Coach K171230 5/26/2017 NDC Calculator, Drug Dose 868.1890 Predictive pulmonary-function value calculator.
Contect Medical Systems Co., LTD Portable ECG Monitor K170954 5/30/2017 DPS Electrocardiograph 870.2340 Electrocardiograph.
Siemens Healthcare GmbH Syngo Dynamics Version VA30 K171053 6/1/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
iRhythm Technologies, Inc. Zio AT ECG Monitoring K163512 6/2/2017 DSI detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Vital Connect, Inc. VitalWatch K170973 6/2/2017 DRG transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
Siemens Healthcare GmbH Syngo Dynamics Version VA30 K171053 6/1/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
iRhythm Technologies, Inc. Zio AT ECG Monitoring K163512 6/2/2017 DSI detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Vital Connect, Inc. VitalWatch K170973 6/2/2017 DRG transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
Insulia Diabetes Management Companion Voluntis S.A. K170669 6/19/2017 NDC Calculator, Drug Dose 868.1890 Predictive pulmonary-function value calculator.
ImPACT Quick Test ImPACT Applications, Inc. K170551 6/21/2017 POM Computerized Cognitive Assessment Aid for Concussion 882.1471 Computerized cognitive assessment aid for concussion
CoVa Monitoring System 2 toSense, Inc. K160899 6/22/2017 MWI monitor,physiological,patient(without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
Enterprise Imaging XERO Viewer Agfa HealthCare N.V. K170434 7/3/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
ViMove2 dorsaVi Ltd K163150 7/14/2017 IKN Electromyograph, Diagnostic 890.1375 Diagnostic electromyograph.
Dario® Blood Glucose Monitoring System LabStyle Innovations K163159 7/19/2017 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
Vital Images, Inc. Vitrea Enterprise Viewer K163232 7/21/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
NovaPACS Novarad Corporation K171754 7/28/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L LifeWatch Services, Inc K170565 8/1/2017 DSI detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
BP5S Wireless Blood Pressure Monitor Andon Health Co., Ltd. K171062 8/1/2017 DXN system, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
Hearing Healthcare Pro DB Diagnostic Systems, Inc. K171038 8/2/2017 ETY Tester, Auditory Impedance 874.1090 Auditory impedance tester.
Clarity Reveal Ceevra, Inc. K171356 8/3/2017 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
OmniTom NeuroLogica Corporation K171183 8/18/2017 JAK System, X-Ray, Tomography, Computed 892.1750 Computed tomography x-ray system.
Optum TeleHealth Application United Health Group Inc. K171406 8/18/2017 DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
Physiotrace NimbleHeart, Inc. K171244 8/23/2017 DRX Electrode, Electrocardiograph 870.2360 Electrocardiograph electrode.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH K170467 8/30/2017 DXN System, Measurement, Blood-Pressure, Non-Invasive 870.1130 Noninvasive blood pressure measurement system.
GrindCare System SUNSTAR SUISSE S.A. K163448 9/1/2017 HCC Device, Biofeedback 882.5050 Biofeedback device.
Prizma G-Medical Innovations Ltd. K170181 9/1/2017 DXH Transmitters And Receivers, Electrocardiograph, Telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
Poseidon Ultrasound System BUTTERFLY NETWORK, INC. K163510 9/6/2017 IYN System, Imaging, Pulsed Doppler, Ultrasonic 892.1550 Ultrasonic pulsed doppler imaging system.
Indego Parker Hannifin Corporation K171334 9/8/2017 PHL Powered Exoskeleton 890.3480 Powered lower extremity exoskeleton.
Clarius Ultrasound System Clarius Mobile Health Corp. K172385 9/14/2017 IYN System, Imaging, Pulsed Doppler, Ultrasonic 892.1550 Ultrasonic pulsed doppler imaging system.
WowGoHealth Blood Glucose Monitoring System Biotest Medical Corporation K171785 9/15/2017 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
Scanostics UTI Check Application Test System Teco Diagnostics K170118 9/21/2017 JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) 862.1510 Nitrite (nonquantitative) test system.
Persyst Mobile App Persyst Development Corporation K171184 9/21/2017 OMB Automatic Event Detection Software For Full-Montage Electroencephalograph 882.1400 Electroencephalograph.
WiTouch Pro, WiTouch, Neubac Hollywog LLC K171599 9/22/2017 NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
Peerbridge Cor(TM) System Peerbridge Health INc. K171936 9/27/2017 DSH Recorder, Magnetic Tape, Medical 870.2800 Medical magnetic tape recorder.
Confirm Rx Insertable Cardiac Monitor (ICM) System St. Jude Medical, Inc. K163407 9/29/2017 MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) 870.2800 Medical magnetic tape recorder.
Carbon Monoxide Breath Sensor System (COBSS) Carrot Sense, Inc. K171408 9/29/2017 CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase 868.1430 Carbon monoxide gas analyzer.
ECG Check - Universal, ECG Check - Universal Plus Cardiac Designs, Inc. K170506 10/2/2017 DXH Transmitters And Receivers, Electrocardiograph, Telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
MSA100BT Peak Flow Meter Beijing M&B Electronic Instruments Co., Ltd. K170281 10/6/2017 BZH Meter, Peak Flow, Spirometry 868.1860 Peak-flow meter for spirometry.
Higi Station (With Body Composition And Pan And Tilt Cuff Housing), Higi Station ( With Body Composition And Fixed Cuff Housing) Higi SH LLC K172739 10/10/2017 DXN system, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
SONON Ultrasound Imaging System, Model: 300L HEALCERION CO., LTD K170085 10/12/2017 IYN System, Imaging, Pulsed Doppler, Ultrasonic 892.1550 Ultrasonic pulsed doppler imaging system.
ECG SENTINEL System Cardiomedix, Inc. K172801 10/18/2017 DXH Transmitters And Receivers, Electrocardiograph, Telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
Avail Omron Healthcare, Inc. K172079 10/19/2017 NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
DentureID Microchip CMP Industries LLC K170423 10/25/2017 PYQ Rfid Chip For Dental Appliance 880.6300 Implantable radiofrequency transponder system for patient identification and health information.
Biim Diagnostic Ultrasound System Biim Ultrasound AS K173138 10/27/2017 IYO System, Imaging, Pulsed Echo, Ultrasonic 892.1560 Ultrasonic pulsed echo imaging system.
Stethee Pro M3dicine Pty. Ltd. K172296 10/30/2017 DQD Stethoscope, Electronic 870.1875 Stethoscope.
Mytens Model: BW-TSX Bewell Connect Corp. K171026 43040 NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter 882.589 Transcutaneous electrical nerve stimulator for pain relief.
JiveX VISUS TECHNOLOGY TRANSFER GMBH K162008 9/16/2016 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
SOFTNETA UAB MedDream K162011 10/14/2016 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
IntelliSpace Portal Platform PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. K162025 10/18/2016 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO., LTD. K162338 9/21/2016 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
Lumify Ultrasound System Philips Healthcare K162549 10/3/2016 IYN System, Imaging, Pulsed Doppler, Ultrasonic 892.1550 Ultrasonic pulsed doppler imaging system.
CALGARY SCIENTIFIC, INC. CALGARY SCIENTIFIC, INC. K161130 8/24/2016 LLZ System, image processing, radiological 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
CareEvent inclusive of the CareEvent Mobile Application accessory PHILIPS MEDICAL SYSTEMS K161164 6/24/2016 MSX System, network and communication, physiological monitors 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
PC ECG EDAN INSTRUMENTS, INC. K161302 7/1/2016 DPS Electrocardiograph 870.2340 Electrocardiograph.
CliniCloud Non-contact Thermometer, Model SPL1024 STETHOCLOUD PTY. LTD (CLINICLOUD) K161325 6/22/2016 FLL Thermometer, Electronic, Clinical 880.2910 Clinical electronic thermometer.
CardioConfirm MORTARA INSTRUMENT, INC. K161465 9/3/2016 DQK Computer, diagnostic, programmable 870.1425 Programmable diagnostic computer.
CUSTOMIZED SOUND THERAPY (CST) TINNITUS OTOSOUND PRODUCTS, LLC K070599 7/13/2007 KLW masker, tinnitus 874.3400 Tinnitus masker.
Synapse 3D Liver and Kidney Analysis FUJIFILM MEDICAL SYSTEMS U.S.A., INC. K142521 12/1/2014 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
AirStrip ONE Web RPM Software AIRSTRIP TECHNOLOGIES, INC. K160073 3/24/2016 MWI Monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
AirStrip RPM AirStrip Technologies, Inc. K160862 9/19/2016 MSX System, network and communication, physiological monitors 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
AGFA HEALTHCARE N.V. AGFA HEALTHCARE N.V. K161061 6/22/2016 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
DENTSPLY SIRONA DENTSPLY SIRONA K161118 7/28/2016 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
CALGARY SCIENTIFIC, INC. CALGARY SCIENTIFIC, INC K161130 8/24/2016 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
NuVasiveNVM5 System NUVASIVE INCORPORATED K152942 2016/01/13 PDQ Neurosurgical Nerve Locator 874.1820 Surgical nerve stimulator/locator.
Quell NEUROMETRIX, INC. K152954 2016/01/05 NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH K153077 2016/02/12 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
AlertWatch: OR ALERTWATCH LLC K153335 2016/03/15 MWI Monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
Electronic Pulse Stimulator JKH HEALTH CO.,LTD. K153520 2016/05/05 NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
Wireless Earlens Light Driven Hearing Aid EARLENS CORPORATION K153634 2016/04/06 PLK Tympanic Membrane Direct Contact Hearing Aid 874.3315  
DICOM Viewer Brainlab AG K153653 2016/04/13 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
TraumaCad Mobile Release 2.0 Voyant Health Ltd K160001 2016/02/12 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
IHealth Track Blood Pressure Monitor Andon Health Co., Ltd K160014 2016/02/02 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
CUR Model 1 Thimble Bioelectronics, Inc. K160052 2016/05/20 NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co., Ltd. K160145 2016/03/13 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
Reveal LINQ MEDTRONIC, INC. K160809 2016/05/26 DSI Detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
ACCU-CHEK Connect Diabetes Management App ROCHE DIAGNOSTICS CORPORATION K141929 2015/03/16 NDC calculator, drug dose 868.1890 Predictive pulmonary-function value calculator.
ACCU-CHEK Connect Diabetes Management App ROCHE DIABETES CARE INC. K150910 2015/06/03 NDC calculator, drug dose 868.1890 Predictive pulmonary-function value calculator.
S HEALTH SAMSUNG ELECTRONICS CO., LTD K132148 2013/12/04 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION GLOOKO, INC K132272 2013/10/17 NBW System, test, blood glucose, over the counter 862.1345 Glucose test system.
ZOLL CODE WRITER ZOLL MEDICAL CORPORATION K132488 2014/04/03 DXJ Display, cathode-ray tube, medical 870.2450 Medical cathode-ray tube display.
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK MEDAPPS INC., DBA ALERE CONNECT K132803 2013/12/12 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
AGAMATRIX HEALTH MANAGER AGAMATRIX INC K132821 2013/11/20 NBW System, test, blood glucose, over the counter 862.1345 Glucose test system.
NOVAPACS NOVARAD CORP. K132853 2014/10/30 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
MYHEALTHPOINT TELEHEALTH MANAGER ENTRA HEALTH SYSTEMS K132930 2014/04/14 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
WITHINGS BLOOD PRESURE MONITOR WITHINGS K133125 2014/03/24 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
IMPAX VOLUME VIEWING 3.0 AGFA HEALTHCARE N.V. K133135 2014/03/07 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
HEALTHINTERLINK BEACON HEALTHINTERLINK, LLC K133252 2014/03/14 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
AIRSTRIP REMOTE PATIENT MONITORING AIRSTRIP TECHNOLOGIES, LP K133394 2014/02/06 MWI Monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
AIRSTRIP REMOTE PATIENT MONITORING AIRSTRIP TECHNOLOGIES, LP K133450 2014/02/14 MWI Monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
RESOLUTIONMD MOBILE CALGARY SCIENTIFIC, INC K133508 2014/03/26 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
MCKESSON CARDIOLOGY ECG MOBILE MCKESSON ISRAEL LTD K133534 2014/04/18 DQK Computer, diagnostic, programmable 870.1425 Programmable diagnostic computer.
FORA CARE BLOOD PRESSURE MONITORING SYSTEM FORA CARE INC. K133588 2014/04/25 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
PHYSIOGLOVE ET SYSTEM COMMWELL R&D LTD. K133703 2014/08/18 DXH Transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR INFOBIONIC, INC K133753 2014/09/19 DSI Detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM ANDON HEALTH CO., LTD K133790 2014/05/22 NBW System, test, blood glucose, over the counter 862.1345 Glucose test system.
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS K134004 2014/02/14 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) REMOTE DIAGNOSTIC TECHNOLOGIES LTD. K134014 2014/08/12 MWI monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
EXTERNAL PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. K141024 2015/01/13 DQA Oximeter 870.2700 Oximeter
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) VITAL CONNECT INC. K141167 2014/07/29 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
ECARE COORDINATOR (ECC) VISICU, INC. K141706 2014/09/09 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
DECISIO HEALTH PATIENT DASHBOARD DECISIO HEALTH, INC. K142106 2015/01/18 MWI Monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
Visage Ease Pro VISAGE IMAGING GMBH K142196 2015/04/28 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
CardiacLinx Ross Medical Technology, Inc K142352 2015/03/12 DSI Detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Master Caution Device MCD HealthWatch Ltd. K142476 2015/02/17 DXH Transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
SPINEDESIGN Spine Surgery Planning (Software Application) MEDTRONIC SOFAMOR DANEK USA, INC K142648 2015/05/22 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
AliveCor Heart Monitor AliveCor, Inc. K142743 2015/01/27 DXH Transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
Pulse Oximeter Shanghai Berry Electronic Tech Co., Ltd K142687 2015/04/13 DQA Oximeter 870.2700 Oximeter
JiveX VISUS TECHNOLOGY TRANSFER GMBH K142750 2015/06/26 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
Triton Canister System Gauss Surgical, Inc. K142801 2015/03/12 PBZ Image Processing Device For Estimation Of External Blood Loss 880.2750  
TraumaCad Mobile Release 1.0 Voyant Health Ltd K142923 2015/03/05 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
Vyntus Walk CAREFUSION GERMANY 234 GMBH K142959 2015/03/20 DQA Oximeter 870.2700 Oximeter
Propeller System 2014-R Reciprocal Labs K142960 2015/03/05 CAF Nebulizer (Direct Patient Interface) 868.5630 Nebulizer
eMotion Faros ECG Mobile MEGA ELECTRONICS LTD K143032 2015/03/29 DXH Transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
Sense4Baby System Model B+ (MSA) AIRSTRIP TECHNOLOGIES, INC K143114 2015/03/10 LQK Home Uterine Activity Monitor 884.2730 Home uterine activity monitor.
UltraLinq ULTRALINQ HEALTHCARE SOLUTIONS, INC. K143176 2015/07/17 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
myVision Track Model 005 VITAL ART AND SCIENCE INCORPORATED K143211 2015/03/20 HPT Perimeter, Automatic, Ac-Powered 886.1330  
TempTraq TT-100 Blue Spark Technologies Inc K143267 2015/09/02 FLL Thermometer, Electronic, Clinical 880.2910 Clinical electronic thermometer.
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector LifeWatch Technologies Ltd K143359 2015/09/11 DSI Detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
ICIS View Agfa HealthCare N.V. K143397 2015/06/01 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
SmartTENS EASYMED INSTRUMENT CO., LTD. K143430 2015/05/29 NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
InvisionECG System InvisionHeart Inc. K143436 2015/05/21 DPS Electrocardiograph 870.2340 Electrocardiograph.
NFANT Feeding Solution NFANT Labs, LLC K143507 2015/09/09 HCC Device, Biofeedback 882.5050 Biofeedback device.
PeriCoach ANALYTICA LTD K143580 2015/03/18 HIR Perineometer 884.1425 Perineometer.
Propeller Model 2014-D Sensor Reciprocal Labs K143671 2015/06/19 CAF Nebulizer (Direct Patient Interface) 868.5630 Nebulizer
Gmate SMART Blood Glucose Monitoring System Philosys Inc K150299 2015/11/19 NBW System, test, blood glucose, over the counter 862.1345 Glucose test system.
Masimo MightySat Rx Fingertip Pulse Oximeter MASIMO CORPORATION K150314 2015/10/22 DQA Oximeter 870.2700 Oximeter
NilRead Perceptive Software K150415 2015/06/12 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor FUDAKANG INDUSTRIAL CO., LTD K150430 2015/04/17 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
Proteus Digital Health Feedback Device PROTEUS DIGITAL HEALTH, INC K150494 2015/06/27 OZW Ingestible Event Marker 880.6305 Ingestible event marker.
Reveal LINQ MEDTRONIC INC. K150614 2015/08/06 DSI Detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Spaulding Electrocardiograph 2100iQ Spaulding Clinical Research, LLC K150564 2015/08/12 DPS Electrocardiograph 870.2340 Electrocardiograph.
zensor system INTELESENS LIMITED K151027 2015/10/02 MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Philips Self-Adhesive Electrodes PHILIPS CONSUMER LIFESTYLE K151033 2015/07/28 GXY Electrode, Cutaneous 882.1320 Cutaneous electrode.
PainKARE TrioWave Technologies K151034 2015/11/21 NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
SmartLinx Vitals Plus Patient Monitoring System CAPSULE TECHNOLOGIE SAS K151071 2015/09/17 MWI Monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) MEDTRONIC MINIMED, INC. K151236 2015/05/19 PJT Continuous Glucose Monitor Secondary Display 862.1350  
Eko Electronic Stethoscope System Eko Devices, Inc. K151319 2015/08/28 DQD stethoscope, electronic 870.1875 Stethoscope
Dentrix Ascend Imaging REALCLOUD IMAGING INC. K151438 2015/07/07 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND K151869 2015/09/02 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
CARESTREAM Vue Motion CARESTREAM HEALTH, INC K151774 2015/09/21 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
Slendertone connect Abs BIO-MEDICAL RESEARCH LTD. K151903 2015/11/06 NGX Stimulator, Muscle, Powered, For Muscle Conditioning 890.5850 Powered muscle stimulator.
iHealth BP3L Wireless Blood Pressure Monitor ANDON HEALTH CO.,LTD K152003 2015/09/24 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
iHealth View BP7S Wireless Blood Pressure Wrist Monitor ANDON HEALTH CO.,LTD K152379 2015/09/23 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
M9/M9CV/M9T Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd K152543 2015/10/29 IYN System, Imaging, Pulsed Doppler, Ultrasonic 892.1550 Ultrasonic pulsed doppler imaging system.
Philips Lumify Diagnostic Ultrasound System PHILIPS HEALTHCARE, INC. K152899 2015/10/30 IYN System, Imaging, Pulsed Doppler, Ultrasonic 892.1550 Ultrasonic pulsed doppler imaging system.
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD K123935 2013/04/12 NBW System, test, blood glucose, over the counter 862.1345 Glucose test system.
ALIVECOR HEART MONITOR ALIVECOR, INC. K130409 2013/09/06 DPS Electrocardiograph 870.2340 Electrocardiograph.
ISIRONA MAGELLAN ISIRONA, LLC K130707 2013/11/20 MSX System,network and communication,physiological monitors 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN K130796 2013/05/09 MWI Monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
OPTUM TELEHEALTH APPLICATION OPTUMHEALTH CARE SOLUTIONS, INC. K130971 2013/10/23 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION DIACOUSTIC MEDICAL DEVICES (PTY) LTD K131044 2013/09/04 DQD Stethoscope, electronic 870.1875 Stethoscope
EMOTION ECG MOBILE MEGA ELECTRONICS LTD K131699 2013/11/26 DXH Transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER AIRSTRIP TECHNOLOGIES, LP K131786 2013/07/03 MWI Monitor,physiological,patient(without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
AIDERA DIASEND SYSTEM AIDERA AB K101806 2010/12/07 MRZ accessories, pump, infusion 880.5725 Infusion pump.
AIRSTRIP OB MP4 SOLUTIONS, LP K042082 2005/01/21 HGM system, monitoring, perinatal 884.2740 Perinatal monitoring system and accessories.
AIRSTRIP OB AIRSTRIP TECHNOLOGIES, LP K090061 2009/01/23 HGM system, monitoring, perinatal 884.2740 Perinatal monitoring system and accessories.
AIRSTRIP OB AIRSTRIP TECHNOLOGIES, LP K090269 2009/02/13 HGM system, monitoring, perinatal 884.2740 Perinatal monitoring system and accessories.
AIRSTRIP REMOTE PATIENT MONITORING AIRSTRIP TECHNOLOGIES, LP K133450 2014/02/14 MWI Monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
AIRSTRIP REMOTE PATIENT MONITORING (RPM) AIRSTRIP TECHNOLOGIES, LP K110503 2011/03/10 MWI monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP K112235 2011/08/26 MWI monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP K121871 2012/07/03 MWI monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 AIRSTRIP TECHNOLOGIES, LP K100133 2010/07/23 MWI monitor, physiological, patient (without arrhythmia detection or alarms) 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
ALIVECOR HEART MONITOR ALIVECOR INC. K140933 2014/08/15 DXH Transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
AliveCor Heart Monitor ALIVECOR INC. K142672 2014/12/03 DXH Transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
ALIVECOR HEART MONITOR FOR IPHONE ALIVECOR, INC. K122356 2012/11/19 DPS electrocardiograph 870.2340 Electrocardiograph.
ALIVECOR HEART MONITOR OTC ALIVECOR INC. K130921 2014/02/06 DPS electrocardiograph 870.2340 Electrocardiograph.
ASTHMAPOLIS SYSTEM RECIPROCAL LABS CORPORATION K121609 2012/07/02 CAF nebulizer (direct patient interface) 868.5630 Nebulizer.
AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB AVITA CORPORATION K072137 2007/12/07 DXN system, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
AYCAN MOBILE AYCAN DIGITALSYSTEME GMBH K122260 2012/09/12 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
BEAM BRUSH/BEAM APP BEAM TECHNOLOGIES, LLC K121165 2012/06/21 EFW toothbrush, manual 872.6855 Manual toothbrush.
BECTON DICKINSON INTELLIPORT SYSTEM BECTON, DICKINSON AND COMPANY K141474 2014/12/18 PHC infusion safety management software 880.5725 Infusion pump.
BIOHARNESS ZEPHYR TECHNOLOGY CORPORATION K113045 2012/08/14 MHX monitor, physiological, patient(with arrhythmia detection or alarms) 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT PREVENTICE, INC. K121197 2012/08/10 DSI detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
CARESTREAM PACS CARESTREAM HEALTH, INC. K110919 2011/10/20 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION CARESTREAM HEALTH INC. K132824 2014/02/06 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL LTD. K110499 2011/04/06 DSI detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. K081257 2008/05/29 DSI detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. K101639 2010/06/25 DSI detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
CG-6108 ARRHYTHMIA ECG EVENT RECORDER CARD GUARD SCIENTIFIC SURVIVAL, LTD. K060911 2006/08/22 DXH transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. K071995 2007/12/18 DXH transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
CONFIDANT 2.5 CONFIDANT INC. K072698 2007/11/16 DRG transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
DANA ANTHROTRONIX, INC. K141865 2014/10/15 LQD Pre-Amendment    
DASH KNEE BRAINLAB AG K102251 2011/05/17 OLO orthopedic stereotaxic instrument 882.4560 Stereotaxic instrument.
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE GE HEALTHCARE K052975 2006/01/20 MSX system,network and communication,physiological monitors 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
DCAS I GP&P CO. K140869 2014/07/03 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 WELLDOC, INC K100066 2010/07/15 LNX medical computers and software Unclassified Unclassified
EBM IDO VIEWER EBM TECHNOLOGIES, INC. K140399 2014/09/18 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
ECARE COORDINATOR (ECC) VISICU, INC. K141706 2014/09/09 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
FAMILY HEALTHWARE SANITAS, INC. K132173 2014/05/30 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
FORA CARE BLOOD PRESSURE MONITORING SYSTEM FOR A CARE INC. K133588 2014/04/25 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC. K020866 2002/06/11 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC. K020866 2002/06/11 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
FRONTIER/ FRONTIER II /ANTHEM FAMILY OF CRT-P'S ST. JUDE MEDICAL P030035/S098 2014/04/10 NKE Pulse generator, pacemaker, implantable    
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 ANDON HEALTH CO.,LTD K102939 2011/02/23 DXN system, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR ANDON HEALTH CO., LTD K121470 2012/06/14 DXN system, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
GENESIS TOUCH SYSTEM HONEYWELL HOMMED K141792 2014/11/25 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 INFOPIA CO., LTD K091168 2010/05/27 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE H2 INC. K141862 2014/12/02 NBW System, test, blood glucose, over the counter 862.1345 Glucose test system.
HEALTHINTERLINK BEACON HEALTHINTERLINK, LLC K133252 2014/03/14 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D AGAMATRIX INC K103544 2011/12/07 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM IDEAL LIFE INC. K132180 2014/06/25 NBW System, test, blood glucose, over the counter 862.1345 Glucose test system.
IEVA REHABILITATIVE POSITIONAL DEVICE REMENDIUM LABS, LLC K133990 2014/10/09 HIR perineometer 884.1425 Perineometer.
IGLUCOSE SYSTEM POSITIVEID CORPORATION K111932 2011/11/10 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM ANDON HEALTH CO., LTD. K133790 2014/05/22 NBW System, test, blood glucose, over the counter 862.1345 Glucose test system.
IMCO-STAT IMCO TECHNOLOGIES K063392 2006/12/12 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
IMPAX VOLUME VIEWING 3.0 AGFA HEALTHCARE NV K133135 2014/03/07 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
INTUITION TERARECON, INC. K121916 2013/04/02 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD K120672 2012/06/01 DXN system, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
MCKESSON CARDIOLOGY ECG MOBILE MCKESSON ISRAEL LTD K133534 2014/04/18 DQK Computer, diagnostic, programmable 870.1425 Programmable diagnostic computer.
MCKESSON RADIOLOGY MCKESSON MEDICAL IMAGING COMPANY K140909 2014/07/02 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 MEDAPPS, INC. K062377 2007/07/03 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG MEDICALGORITHMICS SP Z.O.O. K090037 2009/05/22 DSI detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
MOBILE MIM MIM SOFTWARE INC. K103785 2011/02/04 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
MOBILE MIM MIM SOFTWARE INC. K112930 2011/12/02 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
MOBILECT VIEWER NEPHOSITY, INC. K123082 2013/05/16 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
MOBILE-PATIENT VIEWER DATA CRITICAL CORPORATION K011436 2001/07/05 DPS electrocardiograph 870.2340 Electrocardiograph.
MOBILE-PATIENT VIEWER DATA CRITICAL CORPORATION K011436 2001/07/05 DPS electrocardiograph 870.2340 Electrocardiograph.
MOBIUS ULTRASOUND IMAGING SYSTEM MOBISANTE, INC. K102153 2011/01/20 IYO system, imaging, pulsed echo, ultrasonic 892.1560 Ultrasonic pulsed echo imaging system.
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 CARD GUARD SCIENTIFIC SURVIVAL, LTD. K101703 2010/07/13 DSI detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
MODIFICATION TO: POCKETVIEW ECG SOFTWARE MICROMEDICAL INDUSTRIES, LTD. K013311 2002/01/03 MHX monitor, physiological, patient(with arrhythmia detection or alarms) 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
MODIFICATION TO: POCKETVIEW ECG SOFTWARE MICROMEDICAL INDUSTRIES, LTD. K013311 2002/01/03 MHX monitor, physiological, patient(with arrhythmia detection or alarms) 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR INFOBIONIC, INC. K133753 2014/09/19 DSI Detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS ENTRA HEALTH SYSTEMS, LTD. K081703 2009/01/08 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
MYHEALTHPOINT TELEHEALTH MANAGER ENTRA HEALTH SYSTEMS K132930 2014/04/14 DRG Transmitters and receivers, physiological signal, radiofrequency 870.2910 Radiofrequency physiological signal transmitter and receiver.
MYVISIONTRACK(TM) VITAL ART AND SCIENCE INCORPORATED K121738 2013/02/22 HPT perimeter, automatic, ac-powered 886.1605 Perimeter.
NUVIS DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS HEALTHCARE INC. K133833 2014/01/17 IYN System, Imaging, Pulsed Doppler, Ultrasonic 892.1550 Ultrasonic pulsed doppler imaging system.
ORTHOSIZE ORTHOSIZE LLC K120115 2012/03/14 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
OSTOM-I ALERT 11 HEALTH AND TECHNOLOGIES LLC K140938 2014/10/10 EXB collector, ostomy 876.5900 Ostomy pouch and accessories.
PANOPTIC WELCH ALLYN, INC. K121405 2012/12/20 HKI camera, ophthalmic, ac-powered 886.1120 Ophthalmic camera.
PHYSIOGLOVE ET SYSTEM COMMWELL LTD. K133703 2014/08/18 DXH Transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
PILL PHONE VOCEL K060298 2006/03/29 NXQ reminder, medication 890.5050 Daily activity assist device.
PIXEL APP GAUSS SURGICAL, INC. K120473 2012/04/09 LWH counter, sponge, surgical 880.2740 Surgical sponge scale.
PIXEL APP GAUSS SURGICAL, INC. K121274 2012/06/27 LWH counter, sponge, surgical 880.2740 Surgical sponge scale.
PROPELLER SYSTEM - MODEL 2 RECIPROCAL LABS CORPORATION K140638 2014/05/02 CAF nebulizer (direct patient interface) 868.5630 Nebulizer.
QARDIOARM QARDIO, INC K140067 2014/06/18 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
RAPIDRESULTS RAMSOFT, INC. K141881 2014/10/31 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
REKA E100 REKA PTE LTD K111438 2011/09/12 DPS electrocardiograph 870.2340 Electrocardiograph.
RESOLUTIONMD MOBILE CALGARY SCIENTIFIC INC. K133508 2014/03/26 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 CALGARY SCIENTIFIC, INC. K123186 2013/03/14 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
RESOLUTIONMD MOBILE MODEL RMB-MOB-2X CALGARY SCIENTIFIC, INC. K111346 2011/09/09 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
RHYTHMSTAT XL DATA CRITICAL CORP. K971650 1997/12/04 DXH transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER NORTHEAST MONITORING, INC. K041901 2004/08/31 MWJ electrocardiograph,ambulatory(without analysis) 870.2800 Medical magnetic tape recorder.
SILHOUETTE, MODEL 1000.01 ARANZ MEDICAL LIMITED K070426 2007/06/29 FXN tape, camera, surgical 878.4160 Surgical camera and accessories.
SMARTHEART SHL TELEMEDICINE INTERNATIONAL LTD. K113514 2012/02/22 DXH Transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software SMITH & NEPHEW, INC. K142520 2014/11/20 KTT appliance, fixation, nail/blade/plate combination, multiple component 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY SIGMA INTL. K042121 2004/08/26 FRN pump, infusion 880.5725 Infusion pump.
SURGICASE CONNECT MATERIALISE N.V. K113599 2012/04/27 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
SYMCARE DIABETES MANAGEMENT PROGRAM SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC K083263 2009/03/13 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
SYNGO.VIA WEB VIEWER SIEMENS AG, MEDICAL SOLUTIONS K130998 2014/01/03 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
TABLET VIEWER SOFTWARE FOR IMAGE SUITE CARESTREAM HEALTH INC. K140271 2014/04/01 LLZ System, image processing, radiological 892.2050 Picture archiving and communications system.
TM2005 PERSONAL MEDICAL PHONE CENTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. K024365 2003/01/15 DXH transmitters and receivers, electrocardiograph, telephone 870.2920 Telephone electrocardiograph transmitter and receiver.
VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 WEISSBURG ASSOCIATES K051857 2005/09/15 CCK analyzer, gas, carbon-dioxide, gaseous-phase 868.1400 Carbon dioxide gas analyzer.
VESTIBULAR ANALYSIS APPARATUS CAPACITY SPORTS, LLC K121590 2012/09/20 LXV apparatus, vestibular analysis Pre-Amendment  
VITAL SIGNS PATCH SYSTEM (IN SHORT "VSP") LIFEWATCH TECHNOLOGIES LTD. K132407 2014/12/19 DSI detector and alarm, arrhythmia 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 AGAMATRIX K101597 2010/10/18 NBW system, test, blood glucose, over the counter 862.1345 Glucose test system.
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE GE HEALTHCARE K061994 2006/08/11 MSX system,network and communication,physiological monitors 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM WELLDOC, INC K112370 2011/10/14 MRZ accessories, pump, infusion 880.5725 Infusion pump.
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM WELLDOC, INC K120314 2012/02/24 MRZ accessories, pump, infusion 880.5725 Infusion pump.
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER- RX SYSTEM WELLDOC INC. K141273 2014/07/08 EXB collector, ostomy 876.5900 Ostomy pouch and accessories.
WITHINGS BLOOD PRESSURE MONITOR WITHINGS K110872 2011/05/20 DXN system, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
WITHINGS BLOOD PRESURE MONITOR WITHINGS K133125 2014/03/24 DXN System, measurement, blood-pressure, non-invasive 870.1130 Noninvasive blood pressure measurement system.
WITHINGS, SMART BODY SCALE ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. K121971 2012/09/27 MNW analyzer, body composition 870.2770 Impedance plethysmograph.
Z1 CPAP SYSTEM HUMAN DESIGN MEDICAL, LLC K140929 2014/10/17 BZD ventilator, non-continuous (respirator) 868.5905 Noncontinuous ventilator (IPPB).
ZOLL CODE WRITER ZOLL MEDICAL CORPORATION K132488 2014/04/03 DXJ Display, cathode-ray tube, medical 870.2450 Medical cathode-ray tube display.
ZOLL X SERIES ZOLL MEDICAL CORPORATION K141774 2014/11/19 MKJ automated external defibrillators (non-wearable) 870.5310 Automated external defibrillator system.

 

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