The iNAP One Sleep Therapy System— 510(k) K220907

Name: FDA 510(k) clearance K220907
Creator: U.S. Food and Drug Administration
Published: 2023-06-16

Substantially Equivalent

Somnics, Inc.

FDA 510(k) clearance K220907 for The iNAP One Sleep Therapy System, Substantially Equivalent on 2023-06-16. Applicant: Somnics, Inc.. Device class: 2.

Clearance details

Applicant: Somnics, Inc.
Product code: Code OZR
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2022-03-29
Decision date: 2023-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu County, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code OZR

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K193460 — The iNAP One Sleep Therapy System2020-05-26
K132003 — WINX SLEEP THERAPY SYSTEM2014-06-13
K130538 — WINX SLEEP THERAPY SYSTEM2013-05-22
K122130 — WINX SLEEP THERAPY SYSTEM2012-10-31
K111549 — ATTUNE SLEEP APNEA SYSTEM2012-03-30

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K152660 — HYPNOSPAD2016-11-09

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