Belun Sleep System BLS-100 is an AI-enabled medical device from Belun Technology Company Limited, listed by FDA (510(k), K222579) with a decision date of 2023-02-23. Review panel: Anesthesiology.
| FDA submission number | K222579 |
|---|---|
| Pathway | 510(k) |
| Company | Belun Technology Company Limited |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2023-02-23 |
| Decision | Substantially Equivalent |
| Product code | MNR |
| Classification | Ventilatory Effort Recorder |
| Device class | 2 |
| Regulation number | 868.2375 |
| Review time (calendar days) | 182 |
| Applicant country | CN |
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.