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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 K081445
Device Name FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B
Applicant
TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY,  TW 248
Applicant Contact Yuhua Chen
Correspondent
TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY,  TW 248
Correspondent Contact Yuhua Chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/22/2008
Decision Date 08/11/2008
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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