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FDA 510(k)

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

K-Number: K230292 · 2023-05-02

ApplicantSamsung Electronics Co., Ltd.
Decision Date2023-05-02
Product CodeQDA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

When was Samsung ECG Monitor Application with Irregular Heart Rhythm Notification approved by the FDA?

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

What company makes Samsung ECG Monitor Application with Irregular Heart Rhythm Notification?

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is manufactured by Samsung Electronics Co., Ltd..

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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Related PubMed Literature

PMID: 41395509 The Challenges of Vascular Implants: Regulatory Strategies and Biological Responses. Small science (2025)

Other Devices by Samsung Electronics Co., Ltd.

K163115GC70 K162278Digital Diagnostic Mobile X-ray System K160997GC85A K172229GC85A K171119GM85 K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A

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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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