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 Ventilator, Non-Continuous (Respirator)
510(k) Number K120757
Device Name SLEEPWEAVER ELAN NASAL CPAP MASK
Applicant
Circadiance, LLC
1060 Corporate Ln.
Export,  PA  15632
Applicant Contact DAVID GROLL
Correspondent
Circadiance, LLC
1060 Corporate Ln.
Export,  PA  15632
Correspondent Contact DAVID GROLL
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/13/2012
Decision Date 04/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-