FDA 510(k) Application Details - K151576

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K151576
Device Name	Electrode, Cutaneous
Applicant	Incereb Ltd CENTRE OF APPLIED SCIENCE FOR HEALTH, INSTITUTE OF TECHNOLOGY TALLAGHT DUBLIN DUBLIN24 IE Other 510(k) Applications for this Company
Contact	PAUL PHILLIPS 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	06/11/2015
Decision Date	09/29/2015
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