FDA 510(k) Application Details - K071899

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K071899
Device Name	Index-Generating Electroencephalograph Software
Applicant	MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 REHOVOT 76100 IL Other 510(k) Applications for this Company
Contact	IFAT OREN Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2007
Decision Date	10/22/2007
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