FDA 510(k) Application Details - K183241

Device Classification Name	More FDA Info for this Device
510(K) Number	K183241
Device Name	BrainScope TBI (Model: Ahead 400)
Applicant	BrainScope Company Inc. 4350 East West Hwy, Ste 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	11/21/2018
Decision Date	02/19/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review