FDA 510(k) Application Details - K182967

Device Classification Name	More FDA Info for this Device
510(K) Number	K182967
Device Name	Visor System
Applicant	Cerebrotech Medical Systems, Inc. 1048 Serpentine Lane Suite 301 Pleasanton, CA 94566 US Other 510(k) Applications for this Company
Contact	Dawnel Scott Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2018
Decision Date	11/23/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review