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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 K120712
Model TD-1261
Device Name FORA COMFORTSCAN EAR THERMOMETER
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
6f, no. 127, wugong 2nd rd
wugu district
new taipei county,  TW 248
Original Contact pinjung chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/08/2012
Decision Date 06/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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