Air Next is an AI-enabled medical device from NuvoAir AB, listed by FDA (510(k), K183089) with a decision date of 2020-01-02. Review panel: Anesthesiology.
| FDA submission number | K183089 |
|---|---|
| Pathway | 510(k) |
| Company | NuvoAir AB |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2020-01-02 |
| Decision | Substantially Equivalent |
| Product code | BZG |
| Classification | Spirometer, Diagnostic |
| Device class | 2 |
| Regulation number | 868.1840 |
| Review time (calendar days) | 422 |
| Applicant country | SE |
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.