Onera Sleep Test System (Onera STS)— 510(k) K210593

Substantially Equivalent

Onera B.V.

FDA 510(k) clearance K210593 for Onera Sleep Test System (Onera STS), Substantially Equivalent on 2022-04-06. Applicant: Onera B.V..

Clearance details

Applicant: Onera B.V.
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2021-03-01
Decision date: 2022-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eindhoven, NL

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