FDA 510(k) Application Details - K974718

Device Classification Name Analyzer, Spectrum, Electroencephalogram Signal

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510(K) Number K974718
Device Name Analyzer, Spectrum, Electroencephalogram Signal
Applicant PERSYST DEVELOPMENT CORP.
316 SKYLINE DR.
PRESCOTT, AZ 86303 US
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Contact SCOTT B WILSON
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Regulation Number 882.1420

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Classification Product Code GWS
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Date Received 12/17/1997
Decision Date 03/09/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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