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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Contact EMIN ERALP
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Regulation Number 882.1400

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Classification Product Code GWQ
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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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