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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 K070858
Device Name EXPRESS SERIES
Applicant
Medical Graphics Corp.
350 Oak Grove Pkwy.
St. Paul,  MN  55127 -8599
Applicant Contact MARY E DONLIN
Correspondent
Medical Graphics Corp.
350 Oak Grove Pkwy.
St. Paul,  MN  55127 -8599
Correspondent Contact MARY E DONLIN
Regulation Number868.1730
Classification Product Code
BZL  
Date Received03/28/2007
Decision Date 04/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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