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 a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-08-02 under approval 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. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K240909.
When was Samsung ECG App v 1.3 (ECG) approved by the FDA?
Samsung ECG App v 1.3 (ECG) received FDA 510(k) clearance on 2024-08-02, under approval number K240909.
What company makes Samsung ECG App v 1.3 (ECG)?
Samsung ECG App v 1.3 (ECG) is manufactured by Samsung Electronics Co., Ltd..
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 Devices by Samsung Electronics Co., Ltd.
Related Devices (Code: QDA)
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.