FDA 510(k) Application Details - K120494

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K120494
Device Name	Electrode, Cutaneous
Applicant	SPES MEDICA S.R.L. VIA EUROPA-ZONA INDUSTRIALE BATTIPAGLIA 84091 IT Other 510(k) Applications for this Company
Contact	ALFREDO SPADAVECHIA 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	02/17/2012
Decision Date	06/11/2012
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