510(k) Report

Devices descending from K043010

4 later devices reach Holter Recorder H3+ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152626H3+ Holter RecorderMortara Instrument, Inc.20160—
+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—