FDA 510(k) Application Details - K192753

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K192753
Device Name	Electroencephalograph
Applicant	Medeia, Inc. 7 W Figueroa Street, Suites 300 Santa Barbara, CA 93101 US Other 510(k) Applications for this Company
Contact	Slav Danev Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2019
Decision Date	03/17/2020
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