FDA 510(k) Application Details - K201819

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K201819
Device Name	Electroencephalograph
Applicant	Cadwell Industries, Inc. 909 North Kellogg Street Kennewick, WA 99336 US Other 510(k) Applications for this Company
Contact	Brad Weeks 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	07/01/2020
Decision Date	09/29/2020
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