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 Number | 882.1580
|
Classification Product Code |
|
Date Received | 11/10/2014 |
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
|
|
|