510(k) Report

Devices descending from K142424

3 later devices reach DR300 Holter Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151787Holter SystemEdan Instruments, Inc.20162—
+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—