Withings ECG App is an AI-enabled medical device from Withings, listed by FDA (510(k), K240795) with a decision date of 2025-06-15. Review panel: Cardiovascular.
| FDA submission number | K240795 |
|---|---|
| Pathway | 510(k) |
| Company | Withings |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-06-15 |
| Decision | Substantially Equivalent |
| Product code | QDA |
| Classification | Electrocardiograph Software For Over-The-Counter Use |
| Device class | 2 |
| Regulation number | 870.2345 |
| Review time (calendar days) | 450 |
| Applicant country | FR |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.