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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 K100942
Device Name U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
Applicant
Taidoc Technology Corporation
3f,5f, #127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Applicant Contact NICKY PAN
Correspondent
Taidoc Technology Corporation
3f,5f, #127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Correspondent Contact NICKY PAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/05/2010
Decision Date 05/26/2010
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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