Oxevision Sleep Device is an AI-enabled medical device from Oxehealth Limited, listed by FDA (510(k), K233618) with a decision date of 2024-04-03. Review panel: Neurology.
| FDA submission number | K233618 |
|---|---|
| Pathway | 510(k) |
| Company | Oxehealth Limited |
| Review panel (specialty) | Neurology |
| FDA decision date | 2024-04-03 |
| Decision | Substantially Equivalent |
| Product code | LEL |
| Classification | Device, Sleep Assessment |
| Device class | 2 |
| Regulation number | 882.5050 |
| Review time (calendar days) | 142 |
| Applicant country | GB |
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.