FDA 510(k) Application Details - K112353

Device Classification Name Electroencephalograph

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510(K) Number K112353
Device Name Electroencephalograph
Applicant ELECTRICAL GEODESICS, INC.
29611 SIMMONS ROAD
EUGENE, OR 97405 US
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Contact LINDA J BOVARD
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 08/16/2011
Decision Date 02/17/2012
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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