FDA 510(k) Application Details - K190815

Device Classification Name	More FDA Info for this Device
510(K) Number	K190815
Device Name	BrainScope TBI
Applicant	BrainScope Company, Inc. 4330 East West Highway, Suite #1000 Bethesda, MD 20814 US Other 510(k) Applications for this Company
Contact	Michael 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	03/29/2019
Decision Date	09/11/2019
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