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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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More FDA Info for this Product Code
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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