FDA 510(k) Application Details - K122010

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K122010
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
MINDRAY BUILDING, KEJI 12TH ROAD SOUTH
HI-TECH INDUSTRIAL PARK, NANSHAN
SHENZHEN 518057 CN
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Contact YANG ZHAOHUI
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 07/09/2012
Decision Date 07/20/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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