FDA 510(k) Application Details - K091393

Device Classification Name	Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph   More FDA Info for this Device
510(K) Number	K091393
Device Name	Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant	ELEKTA NEUROMAG OY 8726 FERRARA CT. NAPLES, FL 34114 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2009
Decision Date	10/26/2010
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