FDA 510(k) Application Details - K093304

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K093304
Device Name	Stimulator, Electrical, Evoked Response
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	882.1870   More FDA Info for this Regulation Number
Classification Product Code	GWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/2009
Decision Date	08/11/2010
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