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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
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