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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumotachometer
510(k) Number K990962
Device Name FLOSENSE, MODEL 29-8010
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 Number868.2550
Classification Product Code
JAX  
Date Received03/22/1999
Decision Date 01/07/2000
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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