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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 K240648
Device Name Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
Applicant
Radiant Innovation Inc.
1F, No.3 Industrial E. 9th Rd.,
Science-Based Industrial Park
HsinChu,  TW 300
Applicant Contact Lynn Chen
Correspondent
Radiant Innovation Inc.
1F, No.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
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