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FDA 510(k) Application Details - K974495
Device Classification Name
Electroencephalograph
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510(K) Number
K974495
Device Name
Electroencephalograph
Applicant
NEUROCORP, LTD.
150 WHITE PLAINS RD.
TARRYTOWN, NY 10591 US
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EMIN ERALP
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Regulation Number
882.1400
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Classification Product Code
GWQ
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More FDA Info for this Product Code
Date Received
11/28/1997
Decision Date
02/26/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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