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 Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
510(k) Number K912030
Device Name CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED
Applicant
3M Company
1311 Valencia Ave.
Tustin,  CA  92680
Applicant Contact STEVEN ARICK
Correspondent
3M Company
1311 Valencia Ave.
Tustin,  CA  92680
Correspondent Contact STEVEN ARICK
Regulation Number868.1170
Classification Product Code
CBZ  
Date Received05/07/1991
Decision Date 10/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-