The iNAP One Sleep Therapy System
K-Number: K193460 · 2020-05-26
ApplicantSomnice, Inc.
Decision Date2020-05-26
Product CodeOZR
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
The iNAP One Sleep Therapy System is a medical device manufactured by Somnice, Inc.. It received FDA 510(k) clearance on 2020-05-26 under approval number K193460. The device is classified under product code OZR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the The iNAP One Sleep Therapy System?
The iNAP One Sleep Therapy System is a medical device that received FDA 510(k) clearance on 2020-05-26. It is manufactured by Somnice, Inc.. The 510(k) number is K193460.
When was The iNAP One Sleep Therapy System approved by the FDA?
The iNAP One Sleep Therapy System received FDA 510(k) clearance on 2020-05-26, under approval number K193460.
What company makes The iNAP One Sleep Therapy System?
The iNAP One Sleep Therapy System is manufactured by Somnice, Inc..
What is the FDA product code for The iNAP One Sleep Therapy System?
The FDA product code for The iNAP One Sleep Therapy System is OZR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.