WINX SLEEP THERAPY SYSTEM

Intraoral Pressure Gradient Device

APNICURE, INC.

The following data is part of a premarket notification filed by Apnicure, Inc. with the FDA for Winx Sleep Therapy System.

Pre-market Notification Details

Device IDK132003
510k NumberK132003
Device Name:WINX SLEEP THERAPY SYSTEM
ClassificationIntraoral Pressure Gradient Device
Applicant APNICURE, INC. 900 CHESAPEAKE DR Redwood City,  CA  94063
ContactChris Daniel
CorrespondentChris Daniel
APNICURE, INC. 900 CHESAPEAKE DR Redwood City,  CA  94063
Product CodeOZR  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-01
Decision Date2014-06-13
Summary:summary

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