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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 K040377
Device Name RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
Applicant
RADIANT INNOVATION, INC.
1F,NO. 3,INDUSTRIAL E. 9TH RD
SCIENCE-BASED INDUSTRIAL PARK
HSINCHU,  TW 300
Applicant Contact FRANK LIN
Correspondent
RADIANT INNOVATION, INC.
1F,NO. 3,INDUSTRIAL E. 9TH RD
SCIENCE-BASED INDUSTRIAL PARK
HSINCHU,  TW 300
Correspondent Contact FRANK LIN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/17/2004
Decision Date 09/16/2004
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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