FDA 510(k) Application Details - K141446

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K141446
Device Name	Stimulator, Auditory, Evoked Response
Applicant	NATUS MEDICAL INCORPORATED 5900 FIRST AVENUE SOUTH SEATTLE, WA 98108 US Other 510(k) Applications for this Company
Contact	JUDY BUCKHAM 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	06/02/2014
Decision Date	08/22/2014
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