FDA 510(k) Application Details - K093223

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K093223
Device Name	Electroencephalograph
Applicant	COMPUMEDICS LIMITED 30-40 FLOCKHART STREET ABBOTSFORD, VICTORIA 3067 AU Other 510(k) Applications for this Company
Contact	STUART KING Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/2009
Decision Date	01/15/2010
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