WINX SLEEP THERAPY SYSTEM


Device Classification Name

intraoral pressure gradient device

510(k) Number K122130
Device Name WINX SLEEP THERAPY SYSTEM
Applicant
APNICURE, INC.
900 chesapeake dr
redwood city, 
CA 
94063

Applicant Contact chris daniel
Correspondent
APNICURE, INC.
900 chesapeake dr
redwood city, 
CA 
94063

Correspodent Contact chris daniel
Regulation Number 872.5570
Classification Product Code
OZR  
Date Received 07/18/2012
Decision Date 10/31/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No