510(k) Report

Devices descending from K132437

6 later devices reach Mars Holter Analysis Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG20171—
+1K151787Holter SystemEdan Instruments, Inc.20162—
+1K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc.20150—
+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—
+2K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—