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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K031928
Device Name BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)
Applicant
BRAUN GMBH
6183 PASEO DEL MORTE
SUITE 150
CARLSBAD,  CA  92009
Applicant Contact FRED SCHLADOR
Correspondent
BRAUN GMBH
6183 PASEO DEL MORTE
SUITE 150
CARLSBAD,  CA  92009
Correspondent Contact FRED SCHLADOR
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/23/2003
Decision Date 10/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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