FDA 510(k) Application Details - K982157

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K982157
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant FIELD EFFECTS
300 VESPER EXECUTIVE PARK
TYNGSBOROUGH, MA 01879 US
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Contact GREG HURST
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 06/19/1998
Decision Date 09/02/1998
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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