FDA 510(k) Application Details - K092039

Device Classification Name	Automatic Event Detection Software For Full-Montage Electroencephalograph   More FDA Info for this Device
510(K) Number	K092039
Device Name	Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant	OPTIMA NEUROSCIENCE, INC. 12337 NW 9TH LANE NEWBERRY, FL 32669 US Other 510(k) Applications for this Company
Contact	PAULA WILKERSON Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2009
Decision Date	10/16/2009
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