FDA 510(k) Application Details - K063402

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K063402
Device Name	Electrode, Cutaneous
Applicant	INTELLIGENT HEARING SYSTEMS 6860 S.W. 81ST ST. MIAMI, FL 33143 US Other 510(k) Applications for this Company
Contact	EDWARD MISKIEL Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2006
Decision Date	12/11/2006
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