K253668
- 510(k) number
- K253668
- Device name
- Onera SleepMap (SLEEPMAP)
- Applicant
- Onera B.V. NL
- Product code
- OLZ — Automatic Event Detection Software For Polysomnograp
- Decision date
- 2026-03-08
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K253668.pdf
Official FDA record: K253668
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.