FDA 510(k) Application Details - K202588

Device Classification Name	Normalizing Quantitative Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K202588
Device Name	Normalizing Quantitative Electroencephalograph Software
Applicant	elminda, Ltd 1 Arie Skenkar Street Herzliya 4672501 IL Other 510(k) Applications for this Company
Contact	Keren Elghouzzi-Kazachinsky Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2020
Decision Date	12/07/2020
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