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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K873807
Device Name AUTOTRANSFUSION APPARATUS
Applicant
Biodynamics Corp.
6611 Portwest Dr.
Suite 190
Houston,  TX  77024
Applicant Contact RICHARD L BENSON
Correspondent
Biodynamics Corp.
6611 Portwest Dr.
Suite 190
Houston,  TX  77024
Correspondent Contact RICHARD L BENSON
Regulation Number868.5830
Classification Product Code
CAC  
Date Received09/18/1987
Decision Date 03/09/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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