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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 K915255
Device Name CDI(TM) 300, 400 & 100, MODIFICATION
Applicant
3M Company
1311 Valencia Ave.
Tustin,  CA  92680
Applicant Contact STEVEN M ARICK
Correspondent
3M Company
1311 Valencia Ave.
Tustin,  CA  92680
Correspondent Contact STEVEN M ARICK
Regulation Number870.4330
Classification Product Code
DRY  
Date Received11/18/1991
Decision Date 01/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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