Onera Sleep Test System (Onera STS)— 510(k) K223573

Substantially Equivalent

Onera B.V.

FDA 510(k) clearance K223573 for Onera Sleep Test System (Onera STS), Substantially Equivalent on 2023-08-18. Applicant: Onera B.V..

Clearance details

Applicant: Onera B.V.
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2022-11-30
Decision date: 2023-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eindhoven, NL

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