IRNF App is an AI-enabled medical device from Apple Inc., listed by FDA (510(k), K212516) with a decision date of 2021-10-22. Review panel: Cardiovascular.
| FDA submission number | K212516 |
|---|---|
| Pathway | 510(k) |
| Company | Apple Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2021-10-22 |
| Decision | Substantially Equivalent |
| Product code | QDB |
| Classification | Photoplethysmograph Analysis Software For Over-The-Counter Use |
| Device class | 2 |
| Regulation number | 870.2790 |
| Review time (calendar days) | 73 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Apple Inc. · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.