FDA 510(k) Application Details - K033399

Device Classification Name Electroencephalograph

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510(K) Number K033399
Device Name Electroencephalograph
Applicant ELECTRICAL GEODESICS, INCORPORATED
1630 DUTCH RAVINE COURT
RENO, NV 89521-5160 US
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Contact ROBERT S MCQUATE
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 10/24/2003
Decision Date 08/04/2004
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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