WINX SLEEP THERAPY SYSTEM— 510(k) K132003

Substantially Equivalent

Apnicure, Inc.

FDA 510(k) clearance K132003 for WINX SLEEP THERAPY SYSTEM, Substantially Equivalent on 2014-06-13. Applicant: Apnicure, Inc.. Device class: 2.

Clearance details

Applicant: Apnicure, Inc.
Product code: Code OZR
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2013-07-01
Decision date: 2014-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OZR

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K130538 — WINX SLEEP THERAPY SYSTEM2013-05-22
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Data sourced from openFDA. This site is unofficial and independent of the FDA.