FDA 510(k) Application Details - K031815

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K031815
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant PHILIPS MEDICAL SYSTEMS
22100 BOTHELL EVERETT HWY
P.O. BOX 3003
BOTHELL, WA 98041-8431 US
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Contact LYNN HARMER
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 06/12/2003
Decision Date 09/10/2003
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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