510(k) K201456 ยท DPS Electrocardiograph
Scan Monitor
| Applicant | Withings SA, Issy-Les Moulineaux, FR |
| Decision | Substantially Equivalent, Oct 5, 2021 |
| Received | Jun 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2023 | Withings Scan Monitor/ScanWatch, model number hwa09
Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2) Open, Classified |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.