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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 K150515
Device Name IQSense Flow Sensor Mouthpiece
Applicant
SDI DIAGNOSTICS, INC.
10 HAMPDEN DRIVE
EASTON,  MA  02375
Applicant Contact COSIMO CARIOLO
Correspondent
SDI DIAGNOSTICS, INC.
10 HAMPDEN DRIVE
EASTON,  MA  02375
Correspondent Contact COSIMO CARIOLO
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/02/2015
Decision Date 01/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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