Loss of Pulse Detection is an AI-enabled medical device from Fitbit, listed by FDA (510(k), K242967) with a decision date of 2025-02-25. Review panel: Cardiovascular.
| FDA submission number | K242967 |
|---|---|
| Pathway | 510(k) |
| Company | Fitbit |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-02-25 |
| Decision | Substantially Equivalent |
| Product code | SDY |
| Classification | Loss Of Pulse Notification Software |
| Device class | 2 |
| Regulation number | 870.2790 |
| Review time (calendar days) | 152 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.