FDA 510(k) Application Details - K103719

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K103719
Device Name	Electrode, Cutaneous
Applicant	EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 845 ARONSON LAKE COURT ROSWELL, GA 30075 US Other 510(k) Applications for this Company
Contact	JAY MANSOUR 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	12/21/2010
Decision Date	08/24/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review