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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K901253
Device Name (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000
Applicant
Bio Medicus, Inc.
9600 W. 76 St.
Eden Prairie,  MN  55344
Applicant Contact THOMAS K JOHNSEN
Correspondent
Bio Medicus, Inc.
9600 W. 76 St.
Eden Prairie,  MN  55344
Correspondent Contact THOMAS K JOHNSEN
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received03/16/1990
Decision Date 09/05/1990
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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