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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K103800
Device Name BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
Applicant
KAZ USA, INC (A SUBSIDIARY OF KAZ INC)
250 TURNPIKE ROAD
SOUTHBOROUGH,  MA  01772
Applicant Contact RAJ KASBEKAR
Correspondent
KAZ USA, INC (A SUBSIDIARY OF KAZ INC)
250 TURNPIKE ROAD
SOUTHBOROUGH,  MA  01772
Correspondent Contact RAJ KASBEKAR
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/28/2010
Decision Date 01/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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