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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 K102187
Device Name RII INFRARED EAR THERMOMETER,
Applicant
RADIANT INNOVATION, INC.
1F,NO. 3,INDUSTRIAL E. 9TH RD
SCIENCE-BASED INDUSTRIAL PARK
HSINCHU,  TW 300
Applicant Contact JAMES HUANG
Correspondent
RADIANT INNOVATION, INC.
1F,NO. 3,INDUSTRIAL E. 9TH RD
SCIENCE-BASED INDUSTRIAL PARK
HSINCHU,  TW 300
Correspondent Contact JAMES HUANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/03/2010
Decision Date 12/10/2010
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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