FDA 510(k) Application Details - K031051

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K031051
Device Name	Stimulator, Auditory, Evoked Response
Applicant	INTELLIGENT HEARING SYSTEMS 7356 S.W. 48 ST. MIAMI, FL 33155 US Other 510(k) Applications for this Company
Contact	EDWARD MISKIEL 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	04/02/2003
Decision Date	02/20/2004
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