510(k) Report

Devices descending from K003220

45 later devices reach Personal Ecg Transmitter, Model CG-6550 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060911CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd.200644—
+2K083535Heartrak Smart EcatUniversal Medical, Inc.200817—
+2K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd.2007252
+3K141813Rhythmstar SystemRhythMedix, LLC20148—
+3K131699Emotion Ecg MobileMega Electronics, Ltd.201316—
+3K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+3K101639CG-6108 Act-IL Continuous Ecg Monitor and Arrythmia DetectorCard Guard Scientific Survival, Ltd.201022
+3K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O.20097—
+3K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd.2008182
+4K233584RhythmStar SystemRhythMedix, LLC20241—
+4K183704RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20192—
+4K172311BioFlux DeviceBiotricity, Inc.20171—
+4K172801ECG SENTINEL SystemCardiomedix, Inc.20170—
+4K151269ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd.20160—
+4K143032eMotion Faros ECG MobileMega Electronics, Ltd.20156—
+4K142352CardiacLinxRoss Medical Technology, Inc.20150—
+4K111745King of Hearts Express AF Cardiac Event RecorderCard Guard Scientific Survival, Ltd.20110—
+4K101703Modification to: CG-6108 Act-3L Continuous Ecg Monitor and Arrhythmia Detector, Model…Card Guard Scientific Survival, Ltd.20103—
+4K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+4K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc.20107—
+5K250793RhythmStar System (SL)RhythMedix, LLC20260—
+5K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+5K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+5K161431SimplECGNanowear, Inc.20165—
+5K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC20161—
+5K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+5K151787Holter SystemEdan Instruments, Inc.20162—
+5K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc.20141—
+5K131000V-Patch SystemIntelesens Limited20140—
+5K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+5K110499CG-5108 Act-3L Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd.201122
+6K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+6K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+6K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+6K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—
+6K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+6K231276SmartCardia 7L PlatformSmartcardia SA20230—
+6K201669SimpleSENSENanowear, Inc.20203—
+6K173248CardioskinBioserenity Sas20180—
+6K152491MoMe Software PlatformInfobionic, Inc.20150—
+6K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd.20151—
+7K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+7K212160SimpleSENSE PlatformNanowear, Inc.20211—
+7K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc.20170—
+8K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—