FDA 510(k) Application Details - K113375

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K113375
Device Name	Electrode, Cutaneous
Applicant	ESWALLOW USA 3477 CREEK CIRCLE GUNTERSVILLE, AL 35976 US Other 510(k) Applications for this Company
Contact	WILLIAM INGRAM 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	11/16/2011
Decision Date	01/25/2013
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