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 K042455
Device Name DEVILBISS NASAL CPAP MASK, 9354 SERIES
Applicant
SUNRISE MEDICAL
100 DEVILBISS DR.
SOMERSET,  PA  15501
Applicant Contact ALLAN JONES
Correspondent
SUNRISE MEDICAL
100 DEVILBISS DR.
SOMERSET,  PA  15501
Correspondent Contact ALLAN JONES
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/10/2004
Decision Date 01/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-