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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 K060006
Device Name BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER
Applicant
BRAUN GMBH
P.O. BOX 1490
EAGLE,  ID  83616
Applicant Contact FRED SCHLADOR
Correspondent
BRAUN GMBH
P.O. BOX 1490
EAGLE,  ID  83616
Correspondent Contact FRED SCHLADOR
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/03/2006
Decision Date 01/31/2006
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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