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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 K080921
Device Name SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
Applicant
CHEST M.I., INC.
4-2-1 YUSHIMA, BUNKYO-KU
TOKYO,  JP 113-0034
Applicant Contact FUMIAKI KANAI
Correspondent
CHEST M.I., INC.
4-2-1 YUSHIMA, BUNKYO-KU
TOKYO,  JP 113-0034
Correspondent Contact FUMIAKI KANAI
Regulation Number868.1840
Classification Product Code
BZG  
Date Received04/01/2008
Decision Date 01/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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