510(k) Report

Devices descending from K053263

8 later devices reach Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1003 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc.20107—
+2K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC20161—
+2K151787Holter SystemEdan Instruments, Inc.20162—
+2K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc.20141—
+3K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+3K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+3K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+3K152491MoMe Software PlatformInfobionic, Inc.20150—