FDA 510(k) Application Details - K173617

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K173617
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant Siemens Medical Solutions USA, Inc.
65 Valley Stream Parkway Mailcode 65-1A
Malvern, PA 19533 US
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Contact Cordell L. Fields
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 11/22/2017
Decision Date 03/30/2018
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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