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Electrocardiograph Software For Over-The-Counter Use
FDA product code QDA · Class 2 · Cardiovascular
26
Registered devices
34
Adverse events
0
Recalls
9
510(k) clearances
Devices with this code
Garmin ECG App — Garmin International, Inc.Garmin ECG App — Garmin International, Inc.Samsung ECG Monitor Application — Samsung Electronics Co., Ltd.McKesson — MCKESSON MEDICAL-SURGICAL INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Complete Blood Pressure Monitor +EKG — Omron Healthcare, Inc.Kardia Mobile — Alivecor, Inc.Samsung ECG Monitor Application — Samsung Electronics Co., Ltd.KardiaMobile Card — Alivecor, Inc.KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L+ — Alivecor, Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Samsung ECG Monitor App with Irregular Heart Rhythm Notification — Samsung Electronics Co., Ltd.Samsung ECG Monitor App with Irregular Heart Rhythm Notification — Samsung Electronics Co., Ltd.ECG 2.0 App — APPLE INC.WHOOP ECG Feature — Whoop, Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.ECG App — APPLE INC.Fitbit ECG App — Fitbit LLCECG 2.0 App — APPLE INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Samsung ECG Monitor App 1.3 (with High HR_Android OS) — Samsung Electronics Co., Ltd.Samsung ECG Monitor App 1.3 (with High HR_Wear OS) — Samsung Electronics Co., Ltd.ECG App — APPLE INC.
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