FDA 510(k) Application Details - K232030

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K232030
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant Philips Medical Systems Nederland B.V.
Veenpluis 6
Best 5684PC NL
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Contact Ioana Ulea
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 07/07/2023
Decision Date 08/02/2023
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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