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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory Equipment, Cardiopulmonary Bypass
510(k) Number K874925
Device Name CPE 2000 CARDIO PULMONARY ERGOMETER
Applicant
Medical Graphics Corp.
350 Oak Grove Pkwy.
St. Paul,  MN  55127
Applicant Contact RONALD H BERGESON
Correspondent
Medical Graphics Corp.
350 Oak Grove Pkwy.
St. Paul,  MN  55127
Correspondent Contact RONALD H BERGESON
Regulation Number870.4200
Classification Product Code
KRI  
Date Received12/02/1987
Decision Date 01/19/1988
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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