K201456 is an FDA 510(k) clearance for the Scan Monitor. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Withings SA (Issy-Les Moulineaux, FR). The FDA issued a Cleared decision on October 5, 2021, 491 days after receiving the submission on June 1, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K201456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2020 |
| Decision Date | October 05, 2021 |
| Days to Decision | 491 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |