510(k) Report

Devices descending from K030856

6 later devices reach ER800 Series Ecg Event Recorder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061293Telaheart Digital RecorderNorth East Monitoring, Inc.20065—
+2K142424DR300 Holter MonitorNorth East Monitoring, Inc.20143—
+2K070014Auto Detect for Telaheart DR200/E-aNorth East Monitoring, Inc.20070—
+3K151787Holter SystemEdan Instruments, Inc.20162—
+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—