Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Intraoral Pressure Gradient Device
510(k) Number K132003
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
Correspondent Contact CHRIS DANIEL
Regulation Number872.5570
Classification Product Code
OZR  
Date Received07/01/2013
Decision Date 06/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT01634074
Reviewed by Third Party No
Combination Product No
-
-