FDA 510(k)

Withings ECG App

K-Number: K240795 · 2025-06-15

Decision Date2025-06-15

Product CodeQDA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Withings ECG App is a medical device manufactured by Withings. It received FDA 510(k) clearance on 2025-06-15 under approval number K240795. 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 Withings ECG App?

Withings ECG App is a medical device that received FDA 510(k) clearance on 2025-06-15. It is manufactured by Withings. The 510(k) number is K240795.

When was Withings ECG App approved by the FDA?

Withings ECG App received FDA 510(k) clearance on 2025-06-15, under approval number K240795.

What company makes Withings ECG App?

Withings ECG App is manufactured by Withings.

What is the FDA product code for Withings ECG App?

The FDA product code for Withings ECG App is QDA.

Related Clinical Trials

NCT07595016 Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-eclampsia RECRUITING

Other Devices by Withings

K160544Withings Thermo (Model SCT01) K230812Withings Scan Monitor 2.0 K231667Withings Sleep Rx K252474Withings BeamO (SCT02)

Related Devices (Code: QDA)

DEN180044ECG AppApple, Inc. K201525ECG AppApple, Inc. K200948Fitbit ECG AppFitbit, Inc. K201168ECG Monitor AppSamsung Electronics Co., Ltd. K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd. K221774Garmin ECG AppGarmin International, 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.