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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
Device Name TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND
Applicant
SHENZHEN DELICATE ELECTRONICS CO., LTD.
P.O. BOX 237-023
SHANGHAI,  CN 200237
Applicant Contact Diana Hong
Correspondent
SHENZHEN DELICATE ELECTRONICS CO., LTD.
P.O. BOX 237-023
SHANGHAI,  CN 200237
Correspondent 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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