510(k) Report

Devices descending from K201168

3 later devices reach ECG Monitor App through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243305Masimo W1Masimo Corporation20250—
+1K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.20231—
+2K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.20240—