FDA 510(k) Application Details - K954646

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K954646
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS, OH 44143 US
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Contact ELAINE K KEELER
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 10/10/1995
Decision Date 01/18/1996
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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