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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, predicted values, pulmonary function
510(k) Number K861486
Device Name SPIROMETRY MODULE
Applicant
MEDICAL GRAPHICS CORP.
350 OAK GROVE PKWY.
ST. PAUL,  MN  55127 -8599
Applicant Contact RONALD H BERGESON
Correspondent
MEDICAL GRAPHICS CORP.
350 OAK GROVE PKWY.
ST. PAUL,  MN  55127 -8599
Correspondent Contact RONALD H BERGESON
Regulation Number868.1890
Classification Product Code
BTY  
Date Received04/22/1986
Decision Date 05/19/1986
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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