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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 physiological signal based seizure monitoring system
De Novo Number DEN140033
Device Name Companion
Requester
lgch, inc.
115 n loop, 1604 e.,suite 1203
san antonio,  TX  78232
Contact mike girouard
Regulation Number882.1580
Classification Product Code
POS  
Date Received11/10/2014
Decision Date 02/16/2017
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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