510(k) Report

Devices descending from K990478

19 later devices reach Card Guard, Model CG-6550 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd.2008182
+2K101703Modification to: CG-6108 Act-3L Continuous Ecg Monitor and Arrhythmia Detector, Model…Card Guard Scientific Survival, Ltd.20103—
+2K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+2K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc.20107—
+3K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC20161—
+3K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+3K151787Holter SystemEdan Instruments, Inc.20162—
+3K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc.20141—
+3K131000V-Patch SystemIntelesens Limited20140—
+3K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+3K110499CG-5108 Act-3L Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd.201122
+4K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+4K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+4K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+4K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+4K231276SmartCardia 7L PlatformSmartcardia SA20230—
+4K152491MoMe Software PlatformInfobionic, Inc.20150—
+4K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd.20151—
+5K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc.20170—