Huxley SANSA Home Sleep Apnea Test (1000-00) is an AI-enabled medical device from Huxley Medical, listed by FDA (510(k), K240285) with a decision date of 2024-07-15. Review panel: Anesthesiology.
| FDA submission number | K240285 |
|---|---|
| Pathway | 510(k) |
| Company | Huxley Medical |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2024-07-15 |
| Decision | Substantially Equivalent |
| Product code | MNR |
| Classification | Ventilatory Effort Recorder |
| Device class | 2 |
| Regulation number | 868.2375 |
| Review time (calendar days) | 165 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.