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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Pump Speed, Cardiopulmonary Bypass
510(k) Number K941921
Device Name BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550
Applicant
Medtronic Bio-Medicus, Inc.
9600 W. 76th St.
Eden Prairie,  MN  55344
Applicant Contact THOMAS JOHNSEN
Correspondent
Medtronic Bio-Medicus, Inc.
9600 W. 76th St.
Eden Prairie,  MN  55344
Correspondent Contact THOMAS JOHNSEN
Regulation Number870.4380
Classification Product Code
DWA  
Date Received04/20/1994
Decision Date 07/20/1994
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
Recalls CDRH Recalls
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