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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 K120711
Model KI-8250
Device Name NON-CONTACT THERMOMETER
Original Applicant
K-JUMP HEALTH CO., LTD.
no. 56, wu kung 5th rd.,
new taipei industrial park
new taipei city,  TW 248
Original Contact jm lin
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/08/2012
Decision Date 11/19/2012
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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