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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 K120671
Device Name DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
Original Applicant
COTRONIC TECHNOLOGY LIMITED
west of zhou shi rd
xi xiang st, bao an zone
shen zhen, guang dong,  CH 518126
Original Contact tani mok
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/05/2012
Decision Date 05/17/2013
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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