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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 K953948
Device Name SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO
Applicant
Futuremed America, Inc.
21732 Devonshire St.
Chatsworth,  CA  91313
Applicant Contact MICHAEL DAVIDSON
Correspondent
Futuremed America, Inc.
21732 Devonshire St.
Chatsworth,  CA  91313
Correspondent Contact MICHAEL DAVIDSON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/16/1995
Decision Date 06/25/1996
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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