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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 K092813
Device Name ASTRASONIC SPIROMETER, MODEL 29-8000
Applicant
SDI DIAGNOSTICS, INC.
10 HAMPDEN DR.
EASTON,  MA  02375
Applicant Contact COSIMO CARIOLO
Correspondent
SDI DIAGNOSTICS, INC.
10 HAMPDEN DR.
EASTON,  MA  02375
Correspondent Contact COSIMO CARIOLO
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/14/2009
Decision Date 07/16/2010
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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