510(k) Report

Devices descending from K060911

44 later devices reach CG-6108 Arrhythmia Ecg Event Recorder through their predicates, nearest generation first.

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