FDA 510(k) Application Details - K150204

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K150204
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
KEJI 12TH ROAD
SOUTH, HI-TECH INDUSTRIAL PARK
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 01/29/2015
Decision Date 04/10/2015
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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