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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 K861929
Device Name PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070
Applicant
Medical Graphics Corp.
350 Oak Grove Pkwy.
St. Paul,  MN  55127
Applicant Contact RONALD H BERGESON
Correspondent
Medical Graphics Corp.
350 Oak Grove Pkwy.
St. Paul,  MN  55127
Correspondent Contact RONALD H BERGESON
Regulation Number868.1900
Classification Product Code
BZM  
Date Received05/20/1986
Decision Date 09/26/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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