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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K972962
Device Name 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
Applicant
3M COMPANY
1311 VALENCIA AVE.
TUSTIN,  CA  92680
Applicant Contact ANNE BUTEYN
Correspondent
3M COMPANY
1311 VALENCIA AVE.
TUSTIN,  CA  92680
Correspondent Contact ANNE BUTEYN
Regulation Number870.4330
Classification Product Code
DRY  
Date Received08/11/1997
Decision Date 11/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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