FDA 510(k) Application Details - K140666

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K140666
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
595 MINER RD
CLEVELAND, OH 44143 US
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Contact SUSAN QUICK
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 03/18/2014
Decision Date 06/13/2014
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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