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FDA 510(k) Application Details - K123185
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K123185
Device Name
System, Imaging, Pulsed Echo, 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
ZHAI PEI
Other 510(k) Applications for this Contact
Regulation Number
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
10/10/2012
Decision Date
11/02/2012
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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