FDA 510(k) Application Details - K231457

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K231457
Device Name	Electroencephalograph
Applicant	SPARK Neuro Inc. 212 West 18th Street, Unit 17A New York, NY 10011 US Other 510(k) Applications for this Company
Contact	Marinela Gombosev 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	05/19/2023
Decision Date	08/18/2023
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