FDA 510(k) Application Details - K130885

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K130885
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
757 A ARNOLD DRIVE
MARTINEZ, CA 94553 US
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Contact CHRISTINE DUNBAR
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 03/29/2013
Decision Date 05/17/2013
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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