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

Name: FDA 510(k) clearance K193460
Creator: U.S. Food and Drug Administration
Published: 2020-05-26

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.. Device class: 2.

Clearance details

Applicant: Somnice, Inc.
Product code: Code OZR
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2019-12-16
Decision date: 2020-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu County, TW

Download summary PDF View on FDA.gov ↗

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K220907 — The iNAP One Sleep Therapy System2023-06-16
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K130538 — WINX SLEEP THERAPY SYSTEM2013-05-22
K122130 — WINX SLEEP THERAPY SYSTEM2012-10-31
K111549 — ATTUNE SLEEP APNEA SYSTEM2012-03-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.