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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name neuropsychiatric interpretative electroencephalograph assessment aid
De Novo Number DEN110019
510(K) Number K112711
Device Name NEBA SYSTEM
Requester
lexicor medical technology, llc
753 broad street
suite 701
augusta,  GA  30901
Contact e. howard merry
Regulation Number882.1440
Classification Product Code
NCG  
Date Received12/08/2011
Decision Date 07/15/2013
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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