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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 K992468
Device Name BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER
Applicant
BRAUN GMBH
10421 PACIFIC CENTER COURT
san diego,  CA  92121
Applicant Contact laura guy
Correspondent
BRAUN GMBH
10421 PACIFIC CENTER COURT
san diego,  CA  92121
Correspondent Contact laura guy
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/23/1999
Decision Date 10/20/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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