FDA 510(k) Application Details - K140956

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K140956
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant NORDICNEUROLAB
MOLLENDALSVEIEN 65C
BERGEN, HORDALAND 5009 NO
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Contact CHANDANA G BHANDARI
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 04/14/2014
Decision Date 08/07/2014
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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