Onera SleepMap (SLEEPMAP) is an AI-enabled medical device from Onera B.V., listed by FDA (510(k), K253668) with a decision date of 2026-03-08. Review panel: Neurology.
| FDA submission number | K253668 |
|---|---|
| Pathway | 510(k) |
| Company | Onera B.V. |
| Review panel (specialty) | Neurology |
| FDA decision date | 2026-03-08 |
| Decision | Substantially Equivalent |
| Product code | OLZ |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Device class | 2 |
| Regulation number | 882.1400 |
| Review time (calendar days) | 107 |
| Applicant country | NL |
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.