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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K122710
Models EMS-9PB, EMS-9UA
Device Name TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND
Original Applicant
SHENZHEN DELICATE ELECTRONICS CO., LTD.
p.o. box 237-023
shanghai,  CH 200237
Original Contact diana hong
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   OQQ  
Date Received09/04/2012
Decision Date 02/15/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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