510(k) K253668 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Onera SleepMap (SLEEPMAP)
| Applicant | Onera B.V., Eindhoven, NL |
| Decision | Substantially Equivalent, Mar 8, 2026 |
| Received | Nov 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253668
No recall in the FDA data names this 510(k).
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