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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
510(k) Number K902654
Device Name CDI (TM) SYSTEM 100 MONITORING SYSTEM
Applicant
3M HEALTH CARE, LTD.
2801 BARRANCA RD.
IRVINE,  CA  92714
Applicant Contact JOHN L GEHRICH
Correspondent
3M HEALTH CARE, LTD.
2801 BARRANCA RD.
IRVINE,  CA  92714
Correspondent Contact JOHN L GEHRICH
Regulation Number870.4410
Classification Product Code
DTY  
Subsequent Product Code
DRY  
Date Received06/15/1990
Decision Date 11/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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