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Medical Devices that Incorporate Sensor-based Digital Health Technology

The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate sensor-based digital health technology (sDHT).  

The sDHT medical device list is a resource intended to identify sDHT medical devices that are authorized for marketing in the United States. Digital health innovators can refer to this list to gain insights into the current device landscape and regulatory expectations, which helps foster innovation of safe and effective devices. This list can also provide transparency to health care providers and patients to clearly identify when medical devices use sDHT. In addition, this list can further support the incorporation of sDHTs in medical product development programs, as appropriate.  

Sponsors should engage early with the appropriate Center at the FDA responsible for the medical product under investigation to discuss use of DHTs in a specific clinical investigation.  

Changes in health care have moved care from the hospital environment to the home environment.  sDHT medical devices have the potential to capture information about a person’s health, including in real time outside the clinic.  

Contents of the sDHT Medical Devices List:

  • The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the devices’ overall safety and effectiveness, which includes an evaluation of study appropriateness for the device’s intended use and technological characteristics.
  • A direct link to the FDA’s database entry of a sDHT medical device is provided. The database entry contains releasable information, such as summaries of safety and effectiveness. Note, the summaries are not all inclusive and do not include most of the information that may be included in a submission.
  • The list is not a comprehensive resource of sDHT medical devices. Instead, the list includes sDHT medical devices dating back to 2014, that were identified primarily based on information provided in the summary descriptions of their marketing authorization document.
  • The list includes FDA authorized sDHT devices that are:
    • Non- or minimally invasive,  
    • Wearable (such as smartwatches, rings, patches, and bands),  
    • Designed for continuous or spot check monitoring of individuals' health parameters; and
    • Can be used in non-clinical settings, such as the home.

This list will continue to be updated periodically. sDHT medical devices that have received authorization but for which decision summaries have not been published within the data collection period will be incorporated into a subsequent update.  

Send questions or feedback on this list to digitalhealth@fda.hhs.gov. 

sDHT Medical Devices List

Devices are listed in reverse chronological order by Date of Final Decision. To change the sort order, click the arrows in the column headings.  

Use the Submission Number link to display the approval, authorization, or clearance information for the device in the appropriate FDA database. The database page will include a link to the FDA's publicly available information.

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Date of Final DecisionSubmission NumberDevice CompanyPanel (lead)Primary Product Code
05/05/2025K243603AeviceMDAevice Health Pte. Ltd.CardiovascularDSH
04/25/2025K250153Neu PlatformNeuhealth Digital Ltd.NeurologyGYD
04/09/2025K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc.Clinical ChemistryQBJ
04/04/2025K243236WHOOP ECG (electrocardiogram) Feature (1.0)Whoop, Inc.CardiovascularQDA
04/03/2025K243305Masimo W1Masimo CorporationCardiovascularDPS
03/21/2025K243185REMI Remote EEG Monitoring SystemEpitelNeurologyOMC
03/21/2025K250106Signos Glucose Monitoring SystemSignos, Inc.Clinical ChemistrySAF
03/19/2025K243092AcuPebble Ox (200)Acurable LimitedAnesthesiologyMNR
03/14/2025K241960DeepRESPNox Medical ehfNeurologyOLZ
03/07/2025K243515EpiWatch Monitoring SystemEpiWatch, Inc.NeurologyPOS
02/28/2025K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.CardiovascularDQA
02/25/2025K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.CardiovascularDQA
02/20/2025K242447Falcon HSTCompumedics LimitedNeurologyOLV
02/03/2025K243268TipTraQ (TTQ001)PranaQ Pte. Ltd.AnesthesiologyMNR
01/30/2025K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.CardiovascularDQA
01/28/2025K244027SANSA HSATHuxley MedicalAnesthesiologyMNR
01/14/2025K241066BB-613-BPMBioBeat Technologies Ltd.CardiovascularDXN
01/08/2025K242290DormoTech NLabDormoTech Medical LTDAnesthesiologyMNR
12/09/2024K242508Verily Numetric Retinal CameraVerily Life Sciences, LLCOphthalmicHKI
12/08/2024K240700HomeSleepTest (HST, HST REM+)Somnomedics GMBHNeurologyOLV
11/29/2024K241090Evie Med RingMovano Inc. dba Movano HealthCardiovascularDQA
11/22/2024K242094Dreem 3SBeacon Biosignals, Inc.NeurologyOLZ
11/12/2024K242018UbiqVue™ 2A Multi-parameter System (UX2550)LifeSignals, Inc.CardiovascularDRG
10/31/2024K240653SmartCardia 7L Platform (MCT)SmartCardia SACardiovascularQYX
10/30/2024K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.CardiovascularDSI
10/21/2024K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.CardiovascularQYX
10/17/2024K240408REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, IncNeurologyOMB
09/26/2024K241101BioButton SystemBioIntelliSense Inc.CardiovascularDRG
09/24/2024K240236Happy Ring Health Monitoring SystemHappy Health Inc.CardiovascularMWI
09/13/2024K240929Sleep Apnea Notification Feature (SANF)Apple Inc.AnesthesiologyQZW
09/12/2024DEN230081Hearing Aid Feature (HAF)Apple Inc.Ear Nose & ThroatSCR
09/06/2024K231667Withings Sleep RxWithingsAnesthesiologyMNR
09/04/2024K240646DreamClearSomnoMed Technologies Inc., doing business as REMwareNeurologyGWL
08/28/2024K233827OxiWearOxiWear, Inc.CardiovascularDQA
08/02/2024K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., LtdCardiovascularQDA
07/24/2024P160007/S047Simplera™ SystemMEDTRONIC MINIMEDClinical ChemistryPQF
07/15/2024K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley MedicalAnesthesiologyMNR
06/17/2024K233987VERABAND™Arbor Medical Innovations, LLCNeurologyLEL
06/07/2024K232804FibriCheckQompium nvCardiovascularQME
06/07/2024K233861Libre Rio Continuous Glucose Monitoring SystemAbbott Diabetes CareClinical ChemistrySBH
06/03/2024K240251ANNE ChestSibel Health Inc.CardiovascularDRG
05/29/2024K233655Lingo Glucose SystemAbbottClinical ChemistrySAF
05/09/2024K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte. Ltd.CardiovascularMSX
05/02/2024K232445CSF-4 (CSF-4)CardiacSenseCardiovascularDPS
04/30/2024K233403Flexset SystemZeto, Inc.NeurologyGWQ
04/29/2024DEN230052Eversense AP CGM SystemSenseonics, IncorporatedClinical ChemistrySBA
04/23/2024K240902Dexcom G7 Continuous Glucose Monitoring SystemDexcom Inc.Clinical ChemistryQBJ
04/23/2024K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care Inc.Clinical ChemistryQBJ
03/22/2024K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.CardiovascularMSX
03/05/2024K234070Stelo Glucose Biosensor SystemDexcom, Inc.Clinical ChemistrySAF
03/04/2024K231288VyvoVyvo Technology Corp.(VT)CardiovascularDQA
02/26/2024K234133Dexcom G7 Continuous Glucose Monitoring SystemDexcom Inc.Clinical ChemistryQBJ
02/15/2024K232915EpiMonitorEmpatica SrlNeurologyPOS
02/06/2024DEN230041Sleep Apnea FeatureSamsung Electronics Co., LtdAnesthesiologyQZW
02/04/2024K232210X-trodes System MX-TrodesNeurologyGWL
12/21/2023K231531Pediarity™Gabi SmartCare SACardiovascularDQA
12/15/2023K223721Masimo StorkMasimo CorporationCardiovascularDQA
12/08/2023K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear Inc.CardiovascularDXN
11/30/2023K231546SomfitCompumedics LimitedAnesthesiologyMNR
11/17/2023K232512Masimo W1Masimo CorporationCardiovascularDPS
10/30/2023K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.CardiovascularMWI
08/30/2023K231276SmartCardia 7L PlatformSmartCardia SACardiovascularDSI
08/29/2023K221361circul™ pro RingBodiMetrics, LLCCardiovascularDQA
08/24/2023K231506Current Health SystemCurrent Health LtdCardiovascularMSX
08/23/2023K230812Withings Scan Monitor 2.0WithingsCardiovascularDPS
08/18/2023K223539Dreem 3SBeacon Biosignals, Inc.NeurologyOLZ
08/08/2023K232052Ceribell Instant EEG HeadbandCeribell, Inc.NeurologyGXY
07/21/2023K231173Irregular Rhythm Notification Feature (IRNF)Apple Inc.CardiovascularQDB
07/07/2023K223382AeviceMDAevice Health Pte. Ltd.CardiovascularDSH
06/23/2023K231532ActiGraph LEAP activity monitor (ActiGraph LEAP)ActiGraph, LLCNeurologyLEL
06/01/2023K223676SomniCheckBrainMatterZ, LLCNeurologyGWL
05/15/2023K231081Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.Clinical ChemistryQBJ
05/02/2023K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., LtdCardiovascularQDA
04/13/2023K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care Inc.Clinical ChemistryQBJ
03/17/2023K221772NeuroRPMNew Touch Digital Inc.NeurologyGYD
03/17/2023K223073AlioAlio, Inc.CardiovascularDRG
03/09/2023K221816Wesper LabWesper Inc.AnesthesiologyMNR
03/06/2023K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo CorporationCardiovascularMWI
03/03/2023K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care Inc.Clinical ChemistryQBJ
03/01/2023K222280Bigfoot Unity® Diabetes Management SystemBigfoot Biomedical, Inc.Clinical ChemistryQLG
02/23/2023K222579Belun Sleep System BLS-100Belun Technology Company LimitedAnesthesiologyMNR
02/23/2023K213863Everion+ SystemBiofourmis Singapore Pte. LtdCardiovascularMSX
02/21/2023K223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemAbbott Diabetes Care Inc.Clinical ChemistryQLG
02/15/2023K222389ZEUS SystemiRhythm Technologies, Inc.CardiovascularDQK
01/12/2023K221774Garmin ECG AppGarmin International, Inc.CardiovascularQDA
01/11/2023K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.Clinical ChemistryQBJ
01/06/2023K223675WatchPAT ONE (WP1)Itamar Medical, LTDAnesthesiologyMNR
12/21/2022K220012BresoDX1Bresotec IncAnesthesiologyMNR
12/12/2022K212957BioButton SystemBiolntelliSense Inc.CardiovascularDRG
12/07/2022K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.Clinical ChemistryQBJ
11/20/2022K221282Empatica Health Monitoring PlatformEmpatica S.r.l.CardiovascularDQA
11/18/2022K220351Polso WatchChronisense Medical, Ltd.CardiovascularDQA
11/17/2022K220820Parky AppH2O Bilisim YazilimNeurologyGYD
09/14/2022K222331WatchPAT300 (WP300)Itamar Medical, LtdAnesthesiologyMNR
07/29/2022K221259Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.Clinical ChemistryQBJ
07/19/2022K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.CardiovascularDQK
07/19/2022K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences LLCCardiovascularDXH
07/15/2022K220631NomadAir PMU810Neurotronics, Inc.NeurologyGWL
07/06/2022K213007Cerebra Sleep SystemCerebra Medical Ltd.NeurologyOLV
06/30/2022K220651Wrist Type Blood Pressure MonitorShenzhen Jamr Medical Technology Co., LtdCardiovascularDXN
06/10/2022K213515WesperO2Wesper Inc.CardiovascularDQA
06/10/2022K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.NeurologyGYD
06/03/2022K213971Atrial Fibrillation History FeatureApple Inc.CardiovascularQDB
05/26/2022K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care Inc.Clinical ChemistryQLG
05/26/2022K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care Inc.Clinical ChemistryQLG
05/25/2022K220350KardiaMobile 6LAliveCor, Inc.CardiovascularDXH
04/08/2022K212372Fitbit Irregular Rhythm NotificationsFitbit IncCardiovascularQDB
03/24/2022K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. dba AlioCardiovascularDRG
03/11/2022K211887Personal Kinetigraph (PKG) System Gen 2 PlusGKC Manufacturing Pty LtdNeurologyGYD
02/24/2022K220028NightOwlEctosense nvAnesthesiologyMNR
01/07/2022DEN210015Sunrise Sleep Disorder Diagnostic AidSunriseEar Nose & ThroatQRS
12/21/2021K203343Wesper LabWesper Inc.AnesthesiologyMNR
11/30/2021K211668KardiaMobile CardAliveCor, Inc.CardiovascularDXH
11/22/2021K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care Inc.Clinical ChemistryQLG
10/22/2021K212516IRNF AppApple Inc.CardiovascularQDB
10/21/2021K211407Belun Ring BLR-100XBelun Technology Company LimitedCardiovascularDQA
10/05/2021K201456Scan MonitorWithings SACardiovascularDPS
09/22/2021K212160SimpleSENSE PlatformNanowear Inc.CardiovascularDXH
09/03/2021K210133Current Health Monitoring System Gen 2 (G2)Current HealthCardiovascularMSX
08/30/2021K210805Ceribell Instant EEG HeadbandCeribell, Inc.NeurologyGXY
08/17/2021K203089Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.Clinical ChemistryQDK
08/11/2021K211102FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.Clinical ChemistryQLG
07/30/2021K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care Inc.Clinical ChemistryQLG
07/15/2021K201328Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.Clinical ChemistryQBJ
07/06/2021K210480AcuPebble SAAcurable LimitedAnesthesiologyMNR
06/30/2021K210753KardiaMobile 6LAliveCor, Inc.CardiovascularDXH
06/16/2021K210034EnsoSleepEnsoData, Inc.NeurologyOLZ
06/07/2021K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific CorporationCardiovascularDXN
05/21/2021K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.CardiovascularDQK
05/21/2021K202359Zio MonitoriRhythm Technologies, Inc.CardiovascularDSH
05/07/2021K202145Bigfoot Unity Diabetes Management SystemBigfoot Biomedical, Inc.Clinical ChemistryQLG
04/01/2021K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.CardiovascularDXN
02/06/2021K200276SPEAC SystemBrain Sentinel, Inc.NeurologyPOS
01/27/2021K193386Wrist Electronic SphygmomanometerShenzhen Changkun Technology Co., Ltd.CardiovascularDXN
01/25/2021K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.CardiovascularDQA
12/04/2020K200876Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc.Clinical ChemistryQBJ
11/06/2020K201669SimpleSENSENanowear Inc.CardiovascularDXH
10/08/2020K201525ECG AppApple Inc.CardiovascularQDA
09/25/2020K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.AnesthesiologyBZD
09/11/2020K200948Fitbit ECG AppFitbit, Inc.CardiovascularQDA
08/04/2020K201168ECG Monitor AppSamsung Electronics Co., LtdCardiovascularQDA
07/12/2020K193628AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., LtdCardiovascularDXN
06/12/2020K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care Inc.Clinical ChemistryQLG
06/01/2020K191620Vitls PlatformVitls Inc.CardiovascularDRG
04/20/2020K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)VitalConnect, Inc.CardiovascularDRG
03/06/2020K191031NightOwlEctosense nvAnesthesiologyMNR
02/06/2020K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20VitalConnect, Inc.CardiovascularDRG
01/29/2020K193642Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.Clinical ChemistryQDK
01/24/2020K191406KardiaMobile, KardiaStationAliveCor, Inc.CardiovascularDXH
01/17/2020K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences LLCCardiovascularDXH
12/18/2019K191614BioSticker SystemBioIntelliSense Inc.CardiovascularDRG
12/02/2019K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.CardiovascularDQA
11/13/2019K192469Nox Sleep SystemNox MedicalNeurologyOLZ
10/25/2019K192787Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) SystemDexcom, Inc.Clinical ChemistryQDK
10/18/2019K183625SomnaPatchRespironics, Inc.AnesthesiologyMNR
10/07/2019K191833Dexcom G6 Pro Continuous Glucose Monitoring SystemDexcom, Inc.Clinical ChemistryQII
08/28/2019K182401B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meterAmZetta Technologies Private LimitedCardiovascularMWI
08/23/2019K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.CardiovascularDQK
08/22/2019K190792BB-613WPBioBeat Technologies Ltd.CardiovascularDQA
08/15/2019K183282Biovitals Analytics EngineBiofourmis Singapore Pte. LtdCardiovascularPLB
07/12/2019K191272Wearable Device, Wearable PackageCurrent Health Ltd.CardiovascularMSX
06/28/2019K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc.Clinical ChemistryQBJ
06/25/2019K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.CardiovascularDQA
06/13/2019K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UBHealth & Life Co., Ltd.CardiovascularDXN
06/07/2019K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20VitalConnect, Inc.CardiovascularDRG
05/20/2019K190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TBHealth & Life Co., Ltd.CardiovascularDXN
05/11/2019K182180SPEAC SystemBrain Sentinel, Inc.NeurologyPOS
05/10/2019K183319Triangle SystemAliveCor, Inc.CardiovascularDXH
03/27/2019K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without HomehubCurrent Health LtdCardiovascularMSX
03/07/2019K182344RhythmAnalyticsBiofourmis Singapore Pte. Ltd.CardiovascularDQK
03/07/2019K183078VitalConnect Platform, VitalPatch BiosensorVitalConnect, Inc.CardiovascularDRG
03/01/2019K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.CardiovascularDQA
03/01/2019K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.CardiovascularDQA
02/14/2019K183206Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc.Clinical ChemistryQBJ
01/17/2019K182456Study WatchVerily Life Sciences LLCCardiovascularDXH
12/20/2018K181861EmbraceEmpatica SrlNeurologyPOS
11/21/2018K181996MATRx PlusZephyr Sleep TechnologiesAnesthesiologyMNR
11/16/2018K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc.NeurologyOLV
11/08/2018K182030Faros MobileBittium Biosignals Ltd.CardiovascularMLO
10/26/2018K182041Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc.Clinical ChemistryQDK
09/11/2018DEN180044ECG AppApple IncCardiovascularQDA
09/11/2018DEN180042Irregular Rhythm Notification FeatureApple IncCardiovascularQDB
08/29/2018K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.CardiovascularDQK
08/11/2018K173248CARDIOSKINBioserenity SASCardiovascularDXH
06/21/2018P160048EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEMSenseonics, IncorporatedClinical ChemistryQCD
05/24/2018K181077ActiGraph CentrePoint Insight WatchActiGraphNeurologyLEL
05/08/2018K173510BioStamp nPointMC10 Inc.CardiovascularDRG
03/27/2018DEN170088Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc.Clinical ChemistryQBJ
03/09/2018K162616Wrist Type Blood Pressure MonitorXuzhou Yongkang Electronic Science Technology Co., LtdCardiovascularDXN
01/26/2018K162665MiCor A100 Wearable ECG RecorderMITAC INTERNATIONAL CORP.CardiovascularDPS
01/26/2018K172935EmbraceEmpatica SrlNeurologyPOS
01/10/2018K171833Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology CO., LTDCardiovascularDXN
11/13/2017K172703Disposable Snap ElectrodeEmbla SystemsNeurologyGXY
11/02/2017K163453VitalPatch® VitalConnect PlatformVITAL CONNECT, INC.CardiovascularDRG
08/23/2017K171244PhysiotraceNimbleHeart, Inc.CardiovascularDRX
06/02/2017K163512Zio AT ECG Monitoring SystemIRHYTHM TECHNOLOGIES, INC.CardiovascularQYX
06/02/2017K170973VitalWatch Software User InterfaceVitalConnect, Inc.CardiovascularDRG
04/24/2017K160499Apnea Risk Evaluation System (ARES), Model 620Watermark MedicalAnesthesiologyMNR
02/24/2017K161579Watch-PAT200UITAMAR MEDICAL, LTD.AnesthesiologyMNR
02/16/2017DEN140033CompanionLGCH, INCNeurologyPOS
11/30/2016K161431SimplECGNanowear Inc.CardiovascularDXH
09/20/2016K161717Personal Kinetigraph (PKG) SystemGKC MANUFACTURING PTY LTD.NeurologyGYD
08/01/2016DEN140040Nautilus BrainPulse 1000JAN MEDICAL, INC.NeurologyPOP
07/26/2016K153070Watch-PAT200UITAMAR MEDICAL, LTD.AnesthesiologyMNR
03/29/2016K160336Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.CardiovascularDXN
03/04/2016DEN140017SENSIMED TRIGGERFISHSENSIMED AGOphthalmicPLZ
01/07/2016K153214Full Automatic (NIBP) Blood Pressure MonitorHEALTH & LIFE CO., LTD.CardiovascularDXN
12/06/2015K152139Vital Connect Platform, HealthPatch MD, VitalPatchVITAL CONNECT, INC.CardiovascularDRG
09/29/2015K151576Neon EEGIncereb LtdNeurologyGXY
06/30/2015K151281AGE Automatic Wrist Blood Pressure MonitorDONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTDCardiovascularDXN
06/19/2015K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.CardiovascularDSH
06/03/2015K142159DISPOSABLE PRE-GELLED SURFACE ELECTRODEROCHESTER ELECTRO MEDICAL, INC.NeurologyGXY
04/16/2015K143506BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)COVIDIENNeurologyGXY
04/03/2015K141683ELECTRONIC BLOOD PRESSURE MONITORSHENZHEN URION TECHNOLOGY CO., LTD.CardiovascularDXN
01/30/2015K140861SOMNOTOUCH RESPSOMNOMEDICS GMBHAnesthesiologyMNR
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