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FDA 510(k) Application Details - K091164
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K091164
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
GE MEDICAL SYSTEMS CHINA CO., LTD.
NO. 19 CHANGJIANG ROAD
NATIONAL HI-TECH DEV. ZONE
WUXI, JIANGSU PROVINCE 214028 CN
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Contact
YALAN WU
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
04/22/2009
Decision Date
05/05/2009
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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