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FDA 510(k) Application Details - K090433
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K090433
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD.
NO. 7, SANJIANFANG NANLI
CHAO YANG DISTRICT, BEIJING 100024 CN
Other 510(k) Applications for this Company
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
02/19/2009
Decision Date
03/25/2009
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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