K-number	K223573
Device name	Onera Sleep Test System (Onera STS)
Applicant	Onera B.V.
Product code	MNR
Device class	Class II
Decision date	Aug 18, 2023
Decision	Substantially Equivalent
Regulation	868.2375

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Source

View the full FDA submission: accessdata.fda.gov

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Onera Sleep Test System (Onera STS)

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