FDA 510(k) Application Details - K052579

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K052579
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant PORTAL, INC.
1350 NORTH 200 WEST, #6
P.O. BOX 6141
LOGAN, UT 84341 US
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Contact DAVID CARTER
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 09/20/2005
Decision Date 09/27/2005
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 Y
Expedited Review

FDA Source Information for K052579


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