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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 K070976
Device Name RII INFRARED EAR THERMOMETER, MODEL TH01BN
Applicant
Radiant Innovation, Inc.
1f, # 3 Industrial E. 9th Rd.
Science-Based Industrial Park,
Hsin Chu,  TW
Applicant Contact FRANK LIN
Correspondent
Radiant Innovation, Inc.
1f, # 3 Industrial E. 9th Rd.
Science-Based Industrial Park,
Hsin Chu,  TW
Correspondent Contact FRANK LIN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/06/2007
Decision Date 04/20/2007
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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