FDA 510(k)

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

Número K: K230292 · 2023-05-02

Data da decisão2023-05-02

Código do produtoQDA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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K260481GC85A K261187Hearing Aid Feature K261011Característica de Apneia do Sono (v2.0)K242651GM85 K242478GF85 (models GF85-3P, GF85-SP)K240909Samsung ECG App v 1.3 (ECG)

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Dispositivos Relacionados (Código: 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.

Fonte oficial

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