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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 K040377
Device Name RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
Applicant
Radiant Innovation, Inc.
1f, #3 Industrial E. 9th Rd.,
Science-Based Industrial Park
Hsinchu,  TW 300
Applicant Contact FRANK LIN
Correspondent
Radiant Innovation, Inc.
1f, #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
Predetermined Change
Control Plan Authorized		 No
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