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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Interpretor (Diagnostic)
510(k) Number K896345
Device Name EXERCISE EVALUATION SYSTEM 2010
Applicant
MEDICAL GRAPHICS CORP.
350 OAK GROVE PKWY.
ST. PAUL,  MN  55127 -8599
Applicant Contact KURT MICHLER
Correspondent
MEDICAL GRAPHICS CORP.
350 OAK GROVE PKWY.
ST. PAUL,  MN  55127 -8599
Correspondent Contact KURT MICHLER
Regulation Number868.1900
Classification Product Code
BZM  
Date Received11/03/1989
Decision Date 01/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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