FDA 510(k) Application Details - DEN140033

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140033
Device Name	Companion
Applicant	LGCH, INC 115 N Loop, 1604 E.,Suite 1203 San Antonio, TX 78232 US Other 510(k) Applications for this Company
Contact	Mike Girouard Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2014
Decision Date	02/16/2017
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review