Withings
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories4
Latest FDA decision2025-11-10
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252474 | Withings BeamO (SCT02) | DPS | 2025-11-10 | View |
| 510(k) | K240795 | Withings ECG App | QDA | 2025-06-15 | View |
| 510(k) | K231667 | Withings Sleep Rx | MNR | 2024-09-06 | View |
| 510(k) | K230812 | Withings Scan Monitor 2.0 | DPS | 2023-08-23 | View |
| 510(k) | K160544 | Withings Thermo (Model SCT01) | FLL | 2016-06-17 | View |
No matching devices.
Related Clinical Trials
NCT06637878SCT02 Clinical Accuracy ValidationCOMPLETEDNCT07595016Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-EclampsiaRECRUITINGNCT07631715Withings Hypertension Notification Retrospective StudyACTIVE_NOT_RECRUITINGNCT07654491Withings HFRN Retrospective StudyNOT_YET_RECRUITING