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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 K061731
Device Name MEDGRAPHICS ULTIMA SYSTEM
Applicant
MEDICAL GRAPHICS CORP.
350 OAK GROVE PKWY.
ST. PAUL,  MN  55127 -8599
Applicant Contact LYNN BROSIOUS
Correspondent
MEDICAL GRAPHICS CORP.
350 OAK GROVE PKWY.
ST. PAUL,  MN  55127 -8599
Correspondent Contact LYNN BROSIOUS
Regulation Number868.1730
Classification Product Code
BZL  
Date Received06/20/2006
Decision Date 09/06/2006
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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