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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 K013812
Device Name SPIROLAB II, MODEL 29
Applicant
SDI DIAGNOSTICS, INC.
10 HAMPDEN DR.
EASTON,  MA  02375
Applicant Contact MICHAEL J BOYLE
Correspondent
SDI DIAGNOSTICS, INC.
10 HAMPDEN DR.
EASTON,  MA  02375
Correspondent Contact MICHAEL J BOYLE
Regulation Number868.1840
Classification Product Code
BZG  
Date Received11/15/2001
Decision Date 02/11/2002
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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