Onera SleepMap (SLEEPMAP)— 510(k) K253668
Substantially EquivalentOnera B.V.
FDA 510(k) clearance K253668 for Onera SleepMap (SLEEPMAP), Substantially Equivalent on 2026-03-08. Applicant: Onera B.V.. Device class: 2.
Summary
Onera's Onera SleepMap (SLEEPMAP) is filed under OLZ, automatic event detection software for polysomnographs with electroencephalograph. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Onera filed from Eindhoven, the Netherlands. Review took 107 calendar days (November 21, 2025 to March 8, 2026).
Clearance details
- Applicant
- Onera B.V.
- Product code
- Product code OLZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eindhoven, NL
Recent devices under product code OLZ
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