510(k) Report

Devices descending from K151787

2 later devices reach Holter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+1K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—