Medical Devices

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

Following are some examples of mobile medical applications the FDA has cleared or approved since 1997. The list is intended to show examples of mobile medical apps and does not include all the mobile medical apps we have cleared. 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 (January 9, 2017)

Device NameApplicant510(k) or PMA numberClearance DateProduct CodeProduct Code DescriptionRegulationRegulation Description
JiveXVISUS TECHNOLOGY TRANSFER GMBHK1620089/16/2016LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
SOFTNETA UABMedDreamK16201110/14/2016LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
IntelliSpace Portal PlatformPHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.K16202510/18/2016LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
Full Automatic (NIBP) Blood Pressure MonitorHEALTH & LIFE CO., LTD.K1623389/21/2016DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
Lumify Ultrasound SystemPhilips HealthcareK16254910/3/2016IYNSystem, Imaging, Pulsed Doppler, Ultrasonic892.1550Ultrasonic pulsed doppler imaging system.
CALGARY SCIENTIFIC, INC.CALGARY SCIENTIFIC, INC.K1611308/24/2016LLZSystem, image processing, radiological870.2300Cardiac monitor (including cardiotachometer and rate alarm).
CareEvent inclusive of the CareEvent Mobile Application accessoryPHILIPS MEDICAL SYSTEMSK1611646/24/2016MSXSystem, network and communication, physiological monitors870.2300Cardiac monitor (including cardiotachometer and rate alarm).
PC ECGEDAN INSTRUMENTS, INC.K1613027/1/2016DPSElectrocardiograph870.2340Electrocardiograph.
CliniCloud Non-contact Thermometer, Model SPL1024STETHOCLOUD PTY. LTD (CLINICLOUD)K1613256/22/2016FLLThermometer, Electronic, Clinical880.2910Clinical electronic thermometer.
CardioConfirmMORTARA INSTRUMENT, INC.K1614659/3/2016DQKComputer, diagnostic, programmable870.1425Programmable diagnostic computer.
CUSTOMIZED SOUND THERAPY (CST)TINNITUS OTOSOUND PRODUCTS, LLCK0705997/13/2007KLWmasker, tinnitus874.3400Tinnitus masker.
Synapse 3D Liver and Kidney AnalysisFUJIFILM MEDICAL SYSTEMS U.S.A., INC.K14252112/1/2014LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
AirStrip ONE Web RPM SoftwareAIRSTRIP TECHNOLOGIES, INC.K1600733/24/2016MWIMonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
AirStrip RPMAirStrip Technologies, Inc.K1608629/19/2016MSXSystem, network and communication, physiological monitors870.2300Cardiac monitor (including cardiotachometer and rate alarm).
AGFA HEALTHCARE N.V.AGFA HEALTHCARE N.V.K1610616/22/2016LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
DENTSPLY SIRONADENTSPLY SIRONAK1611187/28/2016LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
CALGARY SCIENTIFIC, INC.CALGARY SCIENTIFIC, INCK1611308/24/2016LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
NuVasiveNVM5 SystemNUVASIVE INCORPORATEDK1529422016/01/13PDQNeurosurgical Nerve Locator874.1820Surgical nerve stimulator/locator.
QuellNEUROMETRIX, INC.K1529542016/01/05NUHStimulator, Nerve, Transcutaneous, Over-The-Counter882.5890Transcutaneous electrical nerve stimulator for pain relief.
Microlife Upper Arm Automatic Digital Blood Pressure MonitorMICROLIFE INTELLECTUAL PROPERTY GMBHK1530772016/02/12DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
AlertWatch: ORALERTWATCH LLCK1533352016/03/15MWIMonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
Electronic Pulse StimulatorJKH HEALTH CO.,LTD.K1535202016/05/05NUHStimulator, Nerve, Transcutaneous, Over-The-Counter882.5890Transcutaneous electrical nerve stimulator for pain relief.
Wireless Earlens Light Driven Hearing AidEARLENS CORPORATIONK1536342016/04/06PLKTympanic Membrane Direct Contact Hearing Aid874.3315 
DICOM ViewerBrainlab AGK1536532016/04/13LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
TraumaCad Mobile Release 2.0Voyant Health LtdK1600012016/02/12LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
IHealth Track Blood Pressure MonitorAndon Health Co., LtdK1600142016/02/02DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
CUR Model 1Thimble Bioelectronics, Inc.K1600522016/05/20NUHStimulator, Nerve, Transcutaneous, Over-The-Counter882.5890Transcutaneous electrical nerve stimulator for pain relief.
Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.K1601452016/03/13DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
Reveal LINQMEDTRONIC, INC.K1608092016/05/26DSIDetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
ACCU-CHEK Connect Diabetes Management AppROCHE DIAGNOSTICS CORPORATIONK1419292015/03/16NDCcalculator, drug dose868.1890Predictive pulmonary-function value calculator.
ACCU-CHEK Connect Diabetes Management AppROCHE DIABETES CARE INC.K1509102015/06/03NDCcalculator, drug dose868.1890Predictive pulmonary-function value calculator.
S HEALTHSAMSUNG ELECTRONICS CO., LTDK1321482013/12/04DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATIONGLOOKO, INCK1322722013/10/17NBWSystem, test, blood glucose, over the counter862.1345Glucose test system.
ZOLL CODE WRITERZOLL MEDICAL CORPORATIONK1324882014/04/03DXJDisplay, cathode-ray tube, medical870.2450Medical cathode-ray tube display.
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINKMEDAPPS INC., DBA ALERE CONNECTK1328032013/12/12DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
AGAMATRIX HEALTH MANAGERAGAMATRIX INCK1328212013/11/20NBWSystem, test, blood glucose, over the counter862.1345Glucose test system.
NOVAPACSNOVARAD CORP.K1328532014/10/30LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
MYHEALTHPOINT TELEHEALTH MANAGERENTRA HEALTH SYSTEMSK1329302014/04/14DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
WITHINGS BLOOD PRESURE MONITORWITHINGSK1331252014/03/24DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
IMPAX VOLUME VIEWING 3.0AGFA HEALTHCARE N.V.K1331352014/03/07LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
HEALTHINTERLINK BEACONHEALTHINTERLINK, LLCK1332522014/03/14DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
AIRSTRIP REMOTE PATIENT MONITORINGAIRSTRIP TECHNOLOGIES, LPK1333942014/02/06MWIMonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
AIRSTRIP REMOTE PATIENT MONITORINGAIRSTRIP TECHNOLOGIES, LPK1334502014/02/14MWIMonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
RESOLUTIONMD MOBILECALGARY SCIENTIFIC, INCK1335082014/03/26LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
MCKESSON CARDIOLOGY ECG MOBILEMCKESSON ISRAEL LTDK1335342014/04/18DQKComputer, diagnostic, programmable870.1425Programmable diagnostic computer.
FORA CARE BLOOD PRESSURE MONITORING SYSTEMFORA CARE INC.K1335882014/04/25DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
PHYSIOGLOVE ET SYSTEMCOMMWELL R&D LTD.K1337032014/08/18DXHTransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTORINFOBIONIC, INCK1337532014/09/19DSIDetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEMANDON HEALTH CO., LTDK1337902014/05/22NBWSystem, test, blood glucose, over the counter862.1345Glucose test system.
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICECELLCO PARTNERSHIP D/B/A VERIZON WIRELESSK1340042014/02/14DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)REMOTE DIAGNOSTIC TECHNOLOGIES LTD.K1340142014/08/12MWImonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
EXTERNAL PULSE OXIMETERBEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.K1410242015/01/13DQAOximeter870.2700Oximeter
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)VITAL CONNECT INC.K1411672014/07/29DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
ECARE COORDINATOR (ECC)VISICU, INC.K1417062014/09/09DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
DECISIO HEALTH PATIENT DASHBOARDDECISIO HEALTH, INC.K1421062015/01/18MWIMonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
Visage Ease ProVISAGE IMAGING GMBHK1421962015/04/28LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
CardiacLinxRoss Medical Technology, IncK1423522015/03/12DSIDetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Master Caution Device MCDHealthWatch Ltd.K1424762015/02/17DXHTransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
SPINEDESIGN Spine Surgery Planning (Software Application)MEDTRONIC SOFAMOR DANEK USA, INCK1426482015/05/22LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
AliveCor Heart MonitorAliveCor, Inc.K1427432015/01/27DXHTransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
Pulse OximeterShanghai Berry Electronic Tech Co., LtdK1426872015/04/13DQAOximeter870.2700Oximeter
JiveXVISUS TECHNOLOGY TRANSFER GMBHK1427502015/06/26LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
Triton Canister SystemGauss Surgical, Inc.K1428012015/03/12PBZImage Processing Device For Estimation Of External Blood Loss880.2750 
TraumaCad Mobile Release 1.0Voyant Health LtdK1429232015/03/05LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
Vyntus WalkCAREFUSION GERMANY 234 GMBHK1429592015/03/20DQAOximeter870.2700Oximeter
Propeller System 2014-RReciprocal LabsK1429602015/03/05CAFNebulizer (Direct Patient Interface)868.5630Nebulizer
eMotion Faros ECG MobileMEGA ELECTRONICS LTDK1430322015/03/29DXHTransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
Sense4Baby System Model B+ (MSA)AIRSTRIP TECHNOLOGIES, INCK1431142015/03/10LQKHome Uterine Activity Monitor884.2730Home uterine activity monitor.
UltraLinqULTRALINQ HEALTHCARE SOLUTIONS, INC.K1431762015/07/17LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
myVision Track Model 005VITAL ART AND SCIENCE INCORPORATEDK1432112015/03/20HPTPerimeter, Automatic, Ac-Powered886.1330 
TempTraq TT-100Blue Spark Technologies IncK1432672015/09/02FLLThermometer, Electronic, Clinical880.2910Clinical electronic thermometer.
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorLifeWatch Technologies LtdK1433592015/09/11DSIDetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
ICIS ViewAgfa HealthCare N.V.K1433972015/06/01LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
SmartTENSEASYMED INSTRUMENT CO., LTD.K1434302015/05/29NUHStimulator, Nerve, Transcutaneous, Over-The-Counter882.5890Transcutaneous electrical nerve stimulator for pain relief.
InvisionECG SystemInvisionHeart Inc.K1434362015/05/21DPSElectrocardiograph870.2340Electrocardiograph.
NFANT Feeding SolutionNFANT Labs, LLCK1435072015/09/09HCCDevice, Biofeedback882.5050Biofeedback device.
PeriCoachANALYTICA LTDK1435802015/03/18HIRPerineometer884.1425Perineometer.
Propeller Model 2014-D SensorReciprocal LabsK1436712015/06/19CAFNebulizer (Direct Patient Interface)868.5630Nebulizer
Gmate SMART Blood Glucose Monitoring SystemPhilosys IncK1502992015/11/19NBWSystem, test, blood glucose, over the counter862.1345Glucose test system.
Masimo MightySat Rx Fingertip Pulse OximeterMASIMO CORPORATIONK1503142015/10/22DQAOximeter870.2700Oximeter
NilReadPerceptive SoftwareK1504152015/06/12LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFUDAKANG INDUSTRIAL CO., LTDK1504302015/04/17DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
Proteus Digital Health Feedback DevicePROTEUS DIGITAL HEALTH, INCK1504942015/06/27OZWIngestible Event Marker880.6305Ingestible event marker.
Reveal LINQMEDTRONIC INC.K1506142015/08/06DSIDetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Spaulding Electrocardiograph 2100iQSpaulding Clinical Research, LLCK1505642015/08/12DPSElectrocardiograph870.2340Electrocardiograph.
zensor systemINTELESENS LIMITEDK1510272015/10/02MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Philips Self-Adhesive ElectrodesPHILIPS CONSUMER LIFESTYLEK1510332015/07/28GXYElectrode, Cutaneous882.1320Cutaneous electrode.
PainKARETrioWave TechnologiesK1510342015/11/21NUHStimulator, Nerve, Transcutaneous, Over-The-Counter882.5890Transcutaneous electrical nerve stimulator for pain relief.
SmartLinx Vitals Plus Patient Monitoring SystemCAPSULE TECHNOLOGIE SASK1510712015/09/17MWIMonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)MEDTRONIC MINIMED, INC.K1512362015/05/19PJTContinuous Glucose Monitor Secondary Display862.1350 
Eko Electronic Stethoscope SystemEko Devices, Inc.K1513192015/08/28DQDstethoscope, electronic870.1875Stethoscope
Dentrix Ascend ImagingREALCLOUD IMAGING INC.K1514382015/07/07LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
Microlife Upper Arm Automatic Digital Blood Pressure MonitorMICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLANDK1518692015/09/02DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
CARESTREAM Vue MotionCARESTREAM HEALTH, INCK1517742015/09/21LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
Slendertone connect AbsBIO-MEDICAL RESEARCH LTD.K1519032015/11/06NGXStimulator, Muscle, Powered, For Muscle Conditioning890.5850Powered muscle stimulator.
iHealth BP3L Wireless Blood Pressure MonitorANDON HEALTH CO.,LTDK1520032015/09/24DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
iHealth View BP7S Wireless Blood Pressure Wrist MonitorANDON HEALTH CO.,LTDK1523792015/09/23DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., LtdK1525432015/10/29IYNSystem, Imaging, Pulsed Doppler, Ultrasonic892.1550Ultrasonic pulsed doppler imaging system.
Philips Lumify Diagnostic Ultrasound SystemPHILIPS HEALTHCARE, INC.K1528992015/10/30IYNSystem, Imaging, Pulsed Doppler, Ultrasonic892.1550Ultrasonic pulsed doppler imaging system.
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEMANDON MEDICAL CO., LTDK1239352013/04/12NBWSystem, test, blood glucose, over the counter862.1345Glucose test system.
ALIVECOR HEART MONITORALIVECOR, INC.K1304092013/09/06DPSElectrocardiograph870.2340Electrocardiograph.
ISIRONA MAGELLANISIRONA, LLCK1307072013/11/20MSXSystem,network and communication,physiological monitors870.2300Cardiac monitor (including cardiotachometer and rate alarm).
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORMCOVIDIENK1307962013/05/09MWIMonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
OPTUM TELEHEALTH APPLICATIONOPTUMHEALTH CARE SOLUTIONS, INC.K1309712013/10/23DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATIONDIACOUSTIC MEDICAL DEVICES (PTY) LTDK1310442013/09/04DQDStethoscope, electronic870.1875Stethoscope
EMOTION ECG MOBILEMEGA ELECTRONICS LTDK1316992013/11/26DXHTransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTERAIRSTRIP TECHNOLOGIES, LPK1317862013/07/03MWIMonitor,physiological,patient(without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
AIDERA DIASEND SYSTEMAIDERA ABK1018062010/12/07MRZaccessories, pump, infusion880.5725Infusion pump.
AIRSTRIP OBMP4 SOLUTIONS, LPK0420822005/01/21HGMsystem, monitoring, perinatal884.2740Perinatal monitoring system and accessories.
AIRSTRIP OBAIRSTRIP TECHNOLOGIES, LPK0900612009/01/23HGMsystem, monitoring, perinatal884.2740Perinatal monitoring system and accessories.
AIRSTRIP OBAIRSTRIP TECHNOLOGIES, LPK0902692009/02/13HGMsystem, monitoring, perinatal884.2740Perinatal monitoring system and accessories.
AIRSTRIP REMOTE PATIENT MONITORINGAIRSTRIP TECHNOLOGIES, LPK1334502014/02/14MWIMonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
AIRSTRIP REMOTE PATIENT MONITORING (RPM)AIRSTRIP TECHNOLOGIES, LPK1105032011/03/10MWImonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAIRSTRIP TECHNOLOGIES, LPK1122352011/08/26MWImonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAIRSTRIP TECHNOLOGIES, LPK1218712012/07/03MWImonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1AIRSTRIP TECHNOLOGIES, LPK1001332010/07/23MWImonitor, physiological, patient (without arrhythmia detection or alarms)870.2300Cardiac monitor (including cardiotachometer and rate alarm).
ALIVECOR HEART MONITORALIVECOR INC.K1409332014/08/15DXHTransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
AliveCor Heart MonitorALIVECOR INC.K1426722014/12/03DXHTransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
ALIVECOR HEART MONITOR FOR IPHONEALIVECOR, INC.K1223562012/11/19DPSelectrocardiograph870.2340Electrocardiograph.
ALIVECOR HEART MONITOR OTCALIVECOR INC.K1309212014/02/06DPSelectrocardiograph870.2340Electrocardiograph.
ASTHMAPOLIS SYSTEMRECIPROCAL LABS CORPORATIONK1216092012/07/02CAFnebulizer (direct patient interface)868.5630Nebulizer.
AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZBAVITA CORPORATIONK0721372007/12/07DXNsystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
AYCAN MOBILEAYCAN DIGITALSYSTEME GMBHK1222602012/09/12LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
BEAM BRUSH/BEAM APPBEAM TECHNOLOGIES, LLCK1211652012/06/21EFWtoothbrush, manual872.6855Manual toothbrush.
BECTON DICKINSON INTELLIPORT SYSTEMBECTON, DICKINSON AND COMPANYK1414742014/12/18PHCinfusion safety management software880.5725Infusion pump.
BIOHARNESSZEPHYR TECHNOLOGY CORPORATIONK1130452012/08/14MHXmonitor, physiological, patient(with arrhythmia detection or alarms)870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECTPREVENTICE, INC.K1211972012/08/10DSIdetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
CARESTREAM PACSCARESTREAM HEALTH, INC.K1109192011/10/20LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATIONCARESTREAM HEALTH INC.K1328242014/02/06LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL LTD.K1104992011/04/06DSIdetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL, LTD.K0812572008/05/29DSIdetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL, LTD.K1016392010/06/25DSIdetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
CG-6108 ARRHYTHMIA ECG EVENT RECORDERCARD GUARD SCIENTIFIC SURVIVAL, LTD.K0609112006/08/22DXHtransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL, LTD.K0719952007/12/18DXHtransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
CONFIDANT 2.5CONFIDANT INC.K0726982007/11/16DRGtransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
DANAANTHROTRONIX, INC.K1418652014/10/15LQDPre-Amendment  
DASH KNEEBRAINLAB AGK1022512011/05/17OLOorthopedic stereotaxic instrument882.4560Stereotaxic instrument.
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWAREGE HEALTHCAREK0529752006/01/20MSXsystem,network and communication,physiological monitors870.2300Cardiac monitor (including cardiotachometer and rate alarm).
DCAS IGP&P CO.K1408692014/07/03LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1WELLDOC, INCK1000662010/07/15LNXmedical computers and softwareUnclassifiedUnclassified
EBM IDO VIEWEREBM TECHNOLOGIES, INC.K1403992014/09/18LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
ECARE COORDINATOR (ECC)VISICU, INC.K1417062014/09/09DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
FAMILY HEALTHWARESANITAS, INC.K1321732014/05/30DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
FORA CARE BLOOD PRESSURE MONITORING SYSTEMFOR A CARE INC.K1335882014/04/25DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEMABBOTT DIABETES CARE INC.K0208662002/06/11NBWsystem, test, blood glucose, over the counter862.1345Glucose test system.
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEMABBOTT DIABETES CARE INC.K0208662002/06/11NBWsystem, test, blood glucose, over the counter862.1345Glucose test system.
FRONTIER/ FRONTIER II /ANTHEM FAMILY OF CRT-P'SST. JUDE MEDICALP030035/S0982014/04/10NKEPulse generator, pacemaker, implantable  
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931ANDON HEALTH CO.,LTDK1029392011/02/23DXNsystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITORANDON HEALTH CO., LTDK1214702012/06/14DXNsystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
GENESIS TOUCH SYSTEMHONEYWELL HOMMEDK1417922014/11/25DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025INFOPIA CO., LTDK0911682010/05/27NBWsystem, test, blood glucose, over the counter862.1345Glucose test system.
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLEH2 INC.K1418622014/12/02NBWSystem, test, blood glucose, over the counter862.1345Glucose test system.
HEALTHINTERLINK BEACONHEALTHINTERLINK, LLCK1332522014/03/14DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV DAGAMATRIX INCK1035442011/12/07NBWsystem, test, blood glucose, over the counter862.1345Glucose test system.
IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEMIDEAL LIFE INC.K1321802014/06/25NBWSystem, test, blood glucose, over the counter862.1345Glucose test system.
IEVA REHABILITATIVE POSITIONAL DEVICEREMENDIUM LABS, LLCK1339902014/10/09HIRperineometer884.1425Perineometer.
IGLUCOSE SYSTEMPOSITIVEID CORPORATIONK1119322011/11/10NBWsystem, test, blood glucose, over the counter862.1345Glucose test system.
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEMANDON HEALTH CO., LTD.K1337902014/05/22NBWSystem, test, blood glucose, over the counter862.1345Glucose test system.
IMCO-STATIMCO TECHNOLOGIESK0633922006/12/12LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
IMPAX VOLUME VIEWING 3.0AGFA HEALTHCARE NVK1331352014/03/07LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
INTUITIONTERARECON, INC.K1219162013/04/02LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITORANDON HEALTH CO.,LTDK1206722012/06/01DXNsystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
MCKESSON CARDIOLOGY ECG MOBILEMCKESSON ISRAEL LTDK1335342014/04/18DQKComputer, diagnostic, programmable870.1425Programmable diagnostic computer.
MCKESSON RADIOLOGYMCKESSON MEDICAL IMAGING COMPANYK1409092014/07/02LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100MEDAPPS, INC.K0623772007/07/03NBWsystem, test, blood glucose, over the counter862.1345Glucose test system.
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECGMEDICALGORITHMICS SP Z.O.O.K0900372009/05/22DSIdetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
MOBILE MIMMIM SOFTWARE INC.K1037852011/02/04LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
MOBILE MIMMIM SOFTWARE INC.K1129302011/12/02LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
MOBILECT VIEWERNEPHOSITY, INC.K1230822013/05/16LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
MOBILE-PATIENT VIEWERDATA CRITICAL CORPORATIONK0114362001/07/05DPSelectrocardiograph870.2340Electrocardiograph.
MOBILE-PATIENT VIEWERDATA CRITICAL CORPORATIONK0114362001/07/05DPSelectrocardiograph870.2340Electrocardiograph.
MOBIUS ULTRASOUND IMAGING SYSTEMMOBISANTE, INC.K1021532011/01/20IYOsystem, imaging, pulsed echo, ultrasonic892.1560Ultrasonic pulsed echo imaging system.
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084CARD GUARD SCIENTIFIC SURVIVAL, LTD.K1017032010/07/13DSIdetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
MODIFICATION TO: POCKETVIEW ECG SOFTWAREMICROMEDICAL INDUSTRIES, LTD.K0133112002/01/03MHXmonitor, physiological, patient(with arrhythmia detection or alarms)870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
MODIFICATION TO: POCKETVIEW ECG SOFTWAREMICROMEDICAL INDUSTRIES, LTD.K0133112002/01/03MHXmonitor, physiological, patient(with arrhythmia detection or alarms)870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTORINFOBIONIC, INC.K1337532014/09/19DSIDetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMSENTRA HEALTH SYSTEMS, LTD.K0817032009/01/08NBWsystem, test, blood glucose, over the counter862.1345Glucose test system.
MYHEALTHPOINT TELEHEALTH MANAGERENTRA HEALTH SYSTEMSK1329302014/04/14DRGTransmitters and receivers, physiological signal, radiofrequency870.2910Radiofrequency physiological signal transmitter and receiver.
MYVISIONTRACK(TM)VITAL ART AND SCIENCE INCORPORATEDK1217382013/02/22HPTperimeter, automatic, ac-powered886.1605Perimeter.
NUVIS DIAGNOSTIC ULTRASOUND SYSTEMPHILIPS HEALTHCARE INC.K1338332014/01/17IYNSystem, Imaging, Pulsed Doppler, Ultrasonic892.1550Ultrasonic pulsed doppler imaging system.
ORTHOSIZEORTHOSIZE LLCK1201152012/03/14LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
OSTOM-I ALERT11 HEALTH AND TECHNOLOGIES LLCK1409382014/10/10EXBcollector, ostomy876.5900Ostomy pouch and accessories.
PANOPTICWELCH ALLYN, INC.K1214052012/12/20HKIcamera, ophthalmic, ac-powered886.1120Ophthalmic camera.
PHYSIOGLOVE ET SYSTEMCOMMWELL LTD.K1337032014/08/18DXHTransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
PILL PHONEVOCELK0602982006/03/29NXQreminder, medication890.5050Daily activity assist device.
PIXEL APPGAUSS SURGICAL, INC.K1204732012/04/09LWHcounter, sponge, surgical880.2740Surgical sponge scale.
PIXEL APPGAUSS SURGICAL, INC.K1212742012/06/27LWHcounter, sponge, surgical880.2740Surgical sponge scale.
PROPELLER SYSTEM - MODEL 2RECIPROCAL LABS CORPORATIONK1406382014/05/02CAFnebulizer (direct patient interface)868.5630Nebulizer.
QARDIOARMQARDIO, INCK1400672014/06/18DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
RAPIDRESULTSRAMSOFT, INC.K1418812014/10/31LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
REKA E100REKA PTE LTDK1114382011/09/12DPSelectrocardiograph870.2340Electrocardiograph.
RESOLUTIONMD MOBILECALGARY SCIENTIFIC INC.K1335082014/03/26LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31CALGARY SCIENTIFIC, INC.K1231862013/03/14LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
RESOLUTIONMD MOBILE MODEL RMB-MOB-2XCALGARY SCIENTIFIC, INC.K1113462011/09/09LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
RHYTHMSTAT XLDATA CRITICAL CORP.K9716501997/12/04DXHtransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDERNORTHEAST MONITORING, INC.K0419012004/08/31MWJelectrocardiograph,ambulatory(without analysis)870.2800Medical magnetic tape recorder.
SILHOUETTE, MODEL 1000.01ARANZ MEDICAL LIMITEDK0704262007/06/29FXNtape, camera, surgical878.4160Surgical camera and accessories.
SMARTHEARTSHL TELEMEDICINE INTERNATIONAL LTD.K1135142012/02/22DXHTransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSMITH & NEPHEW, INC.K1425202014/11/20KTTappliance, fixation, nail/blade/plate combination, multiple component888.3030Single/multiple component metallic bone fixation appliances and accessories.
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARYSIGMA INTL.K0421212004/08/26FRNpump, infusion880.5725Infusion pump.
SURGICASE CONNECTMATERIALISE N.V.K1135992012/04/27LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
SYMCARE DIABETES MANAGEMENT PROGRAMSYMCARE PERSONALIZED HEALTH SOLUTIONS, INCK0832632009/03/13NBWsystem, test, blood glucose, over the counter862.1345Glucose test system.
SYNGO.VIA WEB VIEWERSIEMENS AG, MEDICAL SOLUTIONSK1309982014/01/03LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
TABLET VIEWER SOFTWARE FOR IMAGE SUITECARESTREAM HEALTH INC.K1402712014/04/01LLZSystem, image processing, radiological892.2050Picture archiving and communications system.
TM2005 PERSONAL MEDICAL PHONE CENTERCARD GUARD SCIENTIFIC SURVIVAL, LTD.K0243652003/01/15DXHtransmitters and receivers, electrocardiograph, telephone870.2920Telephone electrocardiograph transmitter and receiver.
VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221WEISSBURG ASSOCIATESK0518572005/09/15CCKanalyzer, gas, carbon-dioxide, gaseous-phase868.1400Carbon dioxide gas analyzer.
VESTIBULAR ANALYSIS APPARATUSCAPACITY SPORTS, LLCK1215902012/09/20LXVapparatus, vestibular analysisPre-Amendment 
VITAL SIGNS PATCH SYSTEM (IN SHORT "VSP")LIFEWATCH TECHNOLOGIES LTD.K1324072014/12/19DSIdetector and alarm, arrhythmia870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4AGAMATRIXK1015972010/10/18NBWsystem, test, blood glucose, over the counter862.1345Glucose test system.
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWAREGE HEALTHCAREK0619942006/08/11MSXsystem,network and communication,physiological monitors870.2300Cardiac monitor (including cardiotachometer and rate alarm).
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMWELLDOC, INCK1123702011/10/14MRZaccessories, pump, infusion880.5725Infusion pump.
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMWELLDOC, INCK1203142012/02/24MRZaccessories, pump, infusion880.5725Infusion pump.
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER- RX SYSTEMWELLDOC INC.K1412732014/07/08EXBcollector, ostomy876.5900Ostomy pouch and accessories.
WITHINGS BLOOD PRESSURE MONITORWITHINGSK1108722011/05/20DXNsystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
WITHINGS BLOOD PRESURE MONITORWITHINGSK1331252014/03/24DXNSystem, measurement, blood-pressure, non-invasive870.1130Noninvasive blood pressure measurement system.
WITHINGS, SMART BODY SCALEZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.K1219712012/09/27MNWanalyzer, body composition870.2770Impedance plethysmograph.
Z1 CPAP SYSTEMHUMAN DESIGN MEDICAL, LLCK1409292014/10/17BZDventilator, non-continuous (respirator)868.5905Noncontinuous ventilator (IPPB).
ZOLL CODE WRITERZOLL MEDICAL CORPORATIONK1324882014/04/03DXJDisplay, cathode-ray tube, medical870.2450Medical cathode-ray tube display.
ZOLL X SERIESZOLL MEDICAL CORPORATIONK1417742014/11/19MKJautomated external defibrillators (non-wearable)870.5310Automated external defibrillator system.

 

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