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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 K812792
Device Name PFT SCREENER (SYSTEM 1100)
Applicant
MEDICAL GRAPHICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDICAL GRAPHICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1890
Classification Product Code
BTY  
Date Received10/06/1981
Decision Date 11/27/1981
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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