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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 K030324
Device Name RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES
Applicant
Radiant Innovation, Inc.
# 40 Ln. 19, Bade Rd.
Hsinchu City,  TW 300
Applicant Contact CHARLES CHANG
Correspondent
Radiant Innovation, Inc.
# 40 Ln. 19, Bade Rd.
Hsinchu City,  TW 300
Correspondent Contact CHARLES CHANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/31/2003
Decision Date 02/27/2003
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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