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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Oxygen-Uptake
510(k) Number K912906
Device Name MEDGRAPHICS PF/DX
Applicant
Medical Graphics Corp.
350 Oak Grove Pkwy.
St. Paul,  MN  55127
Applicant Contact DEAN BRUHN-DINGNDY
Correspondent
Medical Graphics Corp.
350 Oak Grove Pkwy.
St. Paul,  MN  55127
Correspondent Contact DEAN BRUHN-DINGNDY
Regulation Number868.1730
Classification Product Code
BZL  
Date Received07/02/1991
Decision Date 02/04/1992
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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