K213357 is an FDA 510(k) clearance for the Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor. This device is classified as a Transmitters And Receivers, Electrocardiograph, Telephone (Class II - Special Controls, product code DXH).
Submitted by Verily Life Sciences, LLC (South San Francisco, US). The FDA issued a Cleared decision on July 19, 2022, 280 days after receiving the submission on October 12, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.
| 510(k) Number | K213357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2021 |
| Decision Date | July 19, 2022 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXH - Transmitters And Receivers, Electrocardiograph, Telephone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2920 |