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FDA 510(k) Application Details - K131896
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K131896
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
SUZHOU ANKE MEDICAL SYSTEM CO., LTD
P.O. BOX 120-119
SHANGHAI 200120 CN
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Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
892.1000
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Classification Product Code
LNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/25/2013
Decision Date
02/28/2014
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
N
Expedited Review
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