• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name gas-machine, anesthesia
510(k) Number K123125
Model 1009-9050-000
Device Name GE DATEX-OHMEDA AVANCE CS2
Original Applicant
DATEX-OHMEDA, INC.
3030 ohmeda drive
po box 7550
madison,  WI  53707 7550
Original Contact james p raskob
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received10/04/2012
Decision Date 02/06/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-