FDA 510(k) Application Details - K121119

Device Classification Name	Normalizing Quantitative Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K121119
Device Name	Normalizing Quantitative Electroencephalograph Software
Applicant	EIMINDA LTD. 16 HAMINHARA ST. BEIT BACHAR HERZLIYA 46586 IL Other 510(k) Applications for this Company
Contact	DALIA DICKMAN 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	04/12/2012
Decision Date	07/25/2014
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