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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 K200946
Device Name Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
Applicant
Taidoc Technology Corporation
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact Jacky Chou
Correspondent
Taidoc Technology Corporation
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact Jacky Chou
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/08/2020
Decision Date 04/05/2022
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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