FDA 510(k) Application Details - K122034

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K122034
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant PARAMED SRL
CORSO F.M. PERRONE 73R
GENOA 16152 IT
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Contact LUISELLA DEBENEDETTI
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 07/11/2012
Decision Date 12/06/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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