FDA 510(k) Application Details - K093949

Device Classification Name	Amplitude-Integrated Electroencephalograph   More FDA Info for this Device
510(K) Number	K093949
Device Name	Amplitude-Integrated Electroencephalograph
Applicant	NATUS MEDICAL, INC. 2568 BRISTOL CIRCLE OAKVILLE, ONTARIO L6H 5S1 CA Other 510(k) Applications for this Company
Contact	GOLDY SINGH Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2009
Decision Date	06/16/2010
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