510(k) Report

Devices descending from K024323

9 later devices reach Century Series Holter Scanner System, Models C3000, C2000 and C1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053263Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1003Cardionet, Inc.20068—
+2K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc.20107—
+3K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC20161—
+3K151787Holter SystemEdan Instruments, Inc.20162—
+3K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc.20141—
+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—
+4K152491MoMe Software PlatformInfobionic, Inc.20150—