K-number	K193460
Device name	The iNAP One Sleep Therapy System
Applicant	Somnice, Inc.
Product code	OZR
Device class	Class II
Decision date	May 26, 2020
Decision	Substantially Equivalent
Regulation	872.5570

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Source

View the full FDA submission: accessdata.fda.gov

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The iNAP One Sleep Therapy System

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