FDA 510(k) Application Details - K960273

Device Classification Name Automatic Event Detection Software For Full-Montage Electroencephalograph

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510(K) Number K960273
Device Name Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant STELLATE SYSTEMS
345 VICTORIA AVE., SUITE 300
WESTMOUNT, QUEBEC H3Z 2N2 CA
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Contact GEORGE PAPAGIANNIS
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Regulation Number 882.1400

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Classification Product Code OMB
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Date Received 01/19/1996
Decision Date 04/04/1996
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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