FDA 510(k) Application Details - K221959

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K221959
Device Name	Electroencephalograph
Applicant	NeuroField Inc. 386 West Lane Bishop, CA 93514 US Other 510(k) Applications for this Company
Contact	Nicholas J. Dogris 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	07/05/2022
Decision Date	08/31/2023
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