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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 K122221
Model TD-1265
Device Name NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
3f,5f, no.127, wugong 2nd rd.
wugu district
new taipei city,  TW 24888
Original Contact pinjung chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/25/2012
Decision Date 03/29/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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