FDA 510(k) Application Details - K171186

Device Classification Name	More FDA Info for this Device
510(K) Number	K171186
Device Name	Cerebrotech CMS-5000
Applicant	Cerebrotech Medical Systems 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	04/24/2017
Decision Date	12/08/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review