FDA 510(k) Application Details - DEN140025

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140025
Device Name	BrainScope Ahead 100
Applicant	BRAINSCOPE COMPANY, INC 4350 EAST-WEST HWY SUITE 1050 BETHESDA, MD 20814 US Other 510(k) Applications for this Company
Contact	Michael E. Singer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2014
Decision Date	11/17/2014
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	Y