510(k) K253668— Onera SleepMap (SLEEPMAP)

Substantially Equivalent

Onera B.V.

Clearance details

Applicant: Onera B.V.
Product code: Code OLZ
Advisory panel: Neurology
Date received: 2025-11-21
Decision date: 2026-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eindhoven, NL

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