FDA 510(k) Application Details - K240593

Device Classification Name	Non-Normalizing Quantitative Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K240593
Device Name	Non-Normalizing Quantitative Electroencephalograph Software
Applicant	NeuroServo Inc. 2065 Parthenais, Suite 416 Montreal H2K3T1 CA Other 510(k) Applications for this Company
Contact	Nicolas Tremblay Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2024
Decision Date	08/23/2024
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