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FDA 510(k) Application Details - K140030
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K140030
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
BLDG. 9-13 BAIWANGXIN HIGH-TEC
INDUSTRIAL PARK, XILI TOWN
SHENZHEN, NAHSHAN 518108 CN
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Contact
TAN ZHIFENG
Other 510(k) Applications for this Contact
Regulation Number
892.1550
More FDA Info for this Regulation Number
Classification Product Code
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2014
Decision Date
02/19/2014
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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