510(k) Report

Devices descending from K093288

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

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