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 K080439
Device Name SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
Applicant
MALLINCKRODT DEVELOPPEMENT FRANCE
6135 GUNBARELL AVE.
BOULDER,  CO  80301
Applicant Contact TINA DREILING
Correspondent
MALLINCKRODT DEVELOPPEMENT FRANCE
6135 GUNBARELL AVE.
BOULDER,  CO  80301
Correspondent Contact TINA DREILING
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/19/2008
Decision Date 05/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-