Study Watch with Irregular Pulse Monitor is an AI-enabled medical device from Verily Life Sciences LLC, listed by FDA (510(k), K192415) with a decision date of 2020-01-17. Review panel: Cardiovascular.
| FDA submission number | K192415 |
|---|---|
| Pathway | 510(k) |
| Company | Verily Life Sciences LLC |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2020-01-17 |
| Decision | Substantially Equivalent |
| Product code | DXH |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Device class | 2 |
| Regulation number | 870.2920 |
| Review time (calendar days) | 135 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.