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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 K090294
Device Name FORA IR22 EAR THERMOMETER, MODEL TD-1262
Applicant
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 241
Applicant Contact Yuhua Chen
Correspondent
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 241
Correspondent Contact Yuhua Chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/05/2009
Decision Date 02/26/2009
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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