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 K112220
Device Name DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
Applicant
Devilbiss Healthcare, LLC
100 Devilbiss Healthcare
Somerset,  PA  15501
Applicant Contact JAMES P FROEHLICH
Correspondent
Devilbiss Healthcare, LLC
100 Devilbiss Healthcare
Somerset,  PA  15501
Correspondent Contact JAMES P FROEHLICH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/02/2011
Decision Date 11/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-