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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
Predetermined Change
Control Plan Authorized		 No
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