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FDA 510(k)

Samsung ECG App v 1.3 (ECG)

K-Number: K240909 · 2024-08-02

ApplicantSamsung Electronics Co., Ltd.
Decision Date2024-08-02
Product CodeQDA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Samsung ECG App v 1.3 (ECG) 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 2024-08-02 under 510(k) number K240909. 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 App v 1.3 (ECG)?

Samsung ECG App v 1.3 (ECG) is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K240909.

When did Samsung ECG App v 1.3 (ECG) receive FDA 510(k) clearance?

Samsung ECG App v 1.3 (ECG) received FDA 510(k) clearance on 2024-08-02, under 510(k) number K240909.

Who is the listed applicant for Samsung ECG App v 1.3 (ECG)?

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 App v 1.3 (ECG)?

The FDA product code for Samsung ECG App v 1.3 (ECG) is QDA.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261187Hearing Aid FeatureK261011Sleep Apnea Feature (v2.0)K242651GM85K242478GF85 (models GF85-3P, GF85-SP)K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationK222353GM85

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Related Devices (Code: QDA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240795Withings ECG AppWithingsK243236WHOOP ECG (electrocardiogram) Feature (1.0)Whoop., Inc.K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung 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.

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