The following data is part of a premarket notification filed by Withings Sa with the FDA for Scan Monitor.
| Device ID | K201456 |
| 510k Number | K201456 |
| Device Name: | Scan Monitor |
| Classification | Electrocardiograph |
| Applicant | Withings SA 2 Rue Maurice Hartmann Issy-les-moulineaux, FR 92130 |
| Contact | Debreuil Xavier |
| Correspondent | Debreuil Xavier Withings SA 2 Rue Maurice Hartmann Issy-les-moulineaux, FR 92130 |
| Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2021-10-05 |