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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 K083299
Device Name TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER
Applicant
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
New Taipei City,  TW 248
Applicant Contact JEFF WANG
Correspondent
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
New Taipei City,  TW 248
Correspondent Contact JEFF WANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/10/2008
Decision Date 12/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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