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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 K090646
Device Name CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
Applicant
CHEST M.I., INC.
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Applicant Contact JEAN ASQUITH
Correspondent
CHEST M.I., INC.
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Correspondent Contact JEAN ASQUITH
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/11/2009
Decision Date 07/23/2009
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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