Aurora is an AI-enabled medical device from EnsoData, listed by FDA (510(k), K231355) with a decision date of 2024-02-09. Review panel: Anesthesiology.
| FDA submission number | K231355 |
|---|---|
| Pathway | 510(k) |
| Company | EnsoData |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2024-02-09 |
| Decision | Substantially Equivalent |
| Product code | MNR |
| Classification | Ventilatory Effort Recorder |
| Device class | 2 |
| Regulation number | 868.2375 |
| Review time (calendar days) | 275 |
| Applicant country | US |
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.