FDA 510(k) Application Details - K963186

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K963186
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant INNER VISION MRI LTD.
719 CATALPA AVE.
TEANECK, NJ 07666 US
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Contact DIANA UPTON
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 08/14/1996
Decision Date 11/12/1996
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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