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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 K931968
Device Name CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
Applicant
3M Health Care, Ltd.
1311 Valencia Ave.
Tustin,  CA  92680
Applicant Contact STEVEN ARICK
Correspondent
3M Health Care, Ltd.
1311 Valencia Ave.
Tustin,  CA  92680
Correspondent Contact STEVEN ARICK
Regulation Number870.4330
Classification Product Code
DRY  
Date Received04/21/1993
Decision Date 11/10/1993
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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