Airmod is an AI-enabled medical device from Heroic Faith International Ltd., listed by FDA (510(k), K242798) with a decision date of 2025-02-28. Review panel: Anesthesiology.
| FDA submission number | K242798 |
|---|---|
| Pathway | 510(k) |
| Company | Heroic Faith International Ltd. |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2025-02-28 |
| Decision | Substantially Equivalent |
| Product code | BZQ |
| Classification | Monitor, Breathing Frequency |
| Device class | 2 |
| Regulation number | 868.2375 |
| Review time (calendar days) | 165 |
| Applicant country | TW |
Official FDA database record · FDA AI-enabled device list
All Anesthesiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.