Issy-Les-Moulineaux, FR · 4 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DPS | Electrocardiograph | Class II | Cardiovascular | 2 | 2025-11-10 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | Class II | Cardiovascular | 1 | 2025-06-15 |
| MNR | Ventilatory Effort Recorder | Class II | Anesthesiology | 1 | 2024-09-06 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-12-19 | Class II | Ongoing | Z-1280-2023 | Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG… | — | A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a ph… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-11-10 | K252474 | Withings BeamO (SCT02) | DPS | Class II | Cardiovascular |
| 2025-06-15 | K240795 | Withings ECG App | QDA | Class II | Cardiovascular |
| 2024-09-06 | K231667 | Withings Sleep Rx | MNR | Class II | Anesthesiology |
| 2023-08-23 | K230812 | Withings Scan Monitor 2.0 | DPS | Class II | Cardiovascular |