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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 K050463
Device Name CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER
Applicant
Taidoc Technology Corporation
4f, 88, Sec. 1, Kwang Fu Rd.
San Chung, Taipei,  TW 241
Applicant Contact SHU-MEI WU
Correspondent
Taidoc Technology Corporation
4f, 88, Sec. 1, Kwang Fu Rd.
San Chung, Taipei,  TW 241
Correspondent Contact SHU-MEI WU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/23/2005
Decision Date 07/27/2005
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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