FDA 510(k) Application Details - K073665

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K073665
Device Name	Stimulator, Auditory, Evoked Response
Applicant	NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. SAN CARLOS, CA 94070 US Other 510(k) Applications for this Company
Contact	TOM BOLES Other 510(k) Applications for this Contact
Regulation Number	882.1900   More FDA Info for this Regulation Number
Classification Product Code	GWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2007
Decision Date	01/25/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review