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FDA 510(k) Application Details - K121434
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K121434
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
SIEMENS MEDICAL SOLUTIONS, INC.
51 VALLEY STREAM PARKWAY
MAIL CODE D02
MALVERN, PA 19355 US
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Contact
MICHELLE L BYRNE
Other 510(k) Applications for this Contact
Regulation Number
892.1000
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Classification Product Code
LNH
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More FDA Info for this Product Code
Date Received
05/14/2012
Decision Date
11/05/2012
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
N
Expedited Review
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