FDA 510(k) Application Details - K182180

Device Classification Name	More FDA Info for this Device
510(K) Number	K182180
Device Name	SPEAC System
Applicant	Brain Sentinel, Inc. 8023 Vantage Dr., Suite 216 San Antonio, TX 78230 US Other 510(k) Applications for this Company
Contact	Richard Waite Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2018
Decision Date	05/11/2019
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