The iNAP One Sleep Therapy System— 510(k) K193460

Substantially Equivalent

Somnice, Inc.

FDA 510(k) clearance K193460 for The iNAP One Sleep Therapy System, Substantially Equivalent on 2020-05-26. Applicant: Somnice, Inc..

Clearance details

Applicant: Somnice, Inc.
Product code: Code OZR
Advisory panel: Dental
Date received: 2019-12-16
Decision date: 2020-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu County, TW

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