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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K895414
Device Name MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM
Applicant
Integrated Medical Systems, Inc.
15000 W. 6th Ave.
Golden,  CO  80401
Applicant Contact MARY SCHROEDER
Correspondent
Integrated Medical Systems, Inc.
15000 W. 6th Ave.
Golden,  CO  80401
Correspondent Contact MARY SCHROEDER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/01/1989
Decision Date 02/12/1990
Decision Substantially Equivalent (SESE)
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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