FDA 510(k)

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

K-Number: K230292 · 2023-05-02

Decision Date2023-05-02

Product CodeQDA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K230292. The device is classified under product code QDA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification?

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K230292.

When did Samsung ECG Monitor Application with Irregular Heart Rhythm Notification receive FDA 510(k) clearance?

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification received FDA 510(k) clearance on 2023-05-02, under 510(k) number K230292.

Who is the listed applicant for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification?

The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification?

The FDA product code for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is QDA.

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Other records listing Samsung Electronics Co., Ltd. as applicant

K261187Hearing Aid Feature K261011Sleep Apnea Feature (v2.0)K242651GM85 K242478GF85 (models GF85-3P, GF85-SP)K240909Samsung ECG App v 1.3 (ECG)K222353GM85

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Related Devices (Code: QDA)

K240795Withings ECG AppWithings K243236WHOOP ECG (electrocardiogram) Feature (1.0)Whoop., Inc.K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.K221774Garmin ECG AppGarmin International, Inc.K201525ECG AppApple, Inc.K200948Fitbit ECG AppFitbit, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.