FDA 510(k) Application Details - K150688

Device Classification Name	Automatic Event Detection Software For Full-Montage Electroencephalograph   More FDA Info for this Device
510(K) Number	K150688
Device Name	Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant	OPTIMA NEUROSCIENCE, INC. 11930 Research Circle Alachua, FL 32615 US Other 510(k) Applications for this Company
Contact	Ryan T. Kern 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	03/17/2015
Decision Date	11/05/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review