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FDA 510(k) Application Details - K103330
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K103330
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
NO.2, YONG CHANG NORTH RD.
BEIJING ECON.&TECH.DEV.ZONE
BEIJING 100176 CN
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Contact
RUOQIAN LIU
Other 510(k) Applications for this Contact
Regulation Number
892.1000
More FDA Info for this Regulation Number
Classification Product Code
LNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/12/2010
Decision Date
02/11/2011
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
N
Expedited Review
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