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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thermometer, electronic, clinical
510(k) Number K122520
Original Applicant
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu district
new taipei city,  TW 24888
Original Contact pinjung chen
Regulation Number880.2910
Classification Product Code
Date Received08/17/2012
Decision Date 02/05/2013
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