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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 K240648
Device Name Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
Applicant
Radiant Innovation, Inc.
1f, #3 Industrial E. 9th Rd.,
Science-Based Industrial Park
Hsinchu,  TW 300
Applicant Contact Lynn Chen
Correspondent
Radiant Innovation, Inc.
1f, #3 Industrial E. 9th Rd.,
Science-Based Industrial Park
Hsinchu,  TW 300
Correspondent Contact Lynn Chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/07/2024
Decision Date 06/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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