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 Gas-Machine, Anesthesia
510(k) Number K123125
Device Name GE DATEX-OHMEDA AVANCE CS2
Applicant
Datex-Ohmeda., Inc.
3030 Ohmeda Dr., P.O.Box 7550
Madison,  WI  53707 -7550
Applicant Contact JAMES P RASKOB
Correspondent
Datex-Ohmeda., Inc.
3030 Ohmeda Dr., P.O.Box 7550
Madison,  WI  53707 -7550
Correspondent Contact JAMES P RASKOB
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received10/04/2012
Decision Date 02/06/2013
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
Recalls CDRH Recalls
-
-