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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 K061800
Device Name CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER
Applicant
Taidoc Technology Corporation
4f, 88, Sec. 1, Kwang Fu Rd.
San Chung, Taipei,  TW 241
Applicant Contact PI-SHIOU LI
Correspondent
Taidoc Technology Corporation
4f, 88, Sec. 1, Kwang Fu Rd.
San Chung, Taipei,  TW 241
Correspondent Contact PI-SHIOU LI
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/26/2006
Decision Date 07/07/2006
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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