WINX SLEEP THERAPY SYSTEM— 510(k) K130538

Substantially Equivalent

Apnicure, Inc.

FDA 510(k) clearance K130538 for WINX SLEEP THERAPY SYSTEM, Substantially Equivalent on 2013-05-22. 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: 2013-03-01
Decision date: 2013-05-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OZR

K220907 — The iNAP One Sleep Therapy System2023-06-16
K193460 — The iNAP One Sleep Therapy System2020-05-26
K132003 — WINX SLEEP THERAPY SYSTEM2014-06-13
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.