510(k) Report

Devices descending from DEN180044

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221774Garmin ECG AppGarmin International, Inc.20230—
+1K201525ECG AppApple, Inc.20203—
+1K200948Fitbit ECG AppFitbit, Inc.20200—
+1K201168ECG Monitor AppSamsung Electronics Co., Ltd.20203—
+1K191406KardiaMobile, KardiaStationAliveCor, Inc.20202—
+2K240795Withings ECG AppWithings20250—
+2K243236WHOOP ECG (electrocardiogram) Feature (1.0)Whoop., Inc.20250—
+2K243305Masimo W1Masimo Corporation20250—
+2K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.20240—
+2K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.20231—
+2K211668KardiaMobile CardAliveCor, Inc.20210—
+2K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20210—