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FDA 510(k) Applications Submitted by Onera B.V.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K210593
03/01/2021
Onera Sleep Test System (Onera STS)
Onera B.V.
K223573
11/30/2022
Onera Sleep Test System (Onera STS)
Onera B.V.
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