FDA 510(k) Application Details - K142159

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K142159
Device Name	Electrode, Cutaneous
Applicant	ROCHESTER ELECTRO MEDICAL, INC. 19404 PINE VALLEY DRIVE ODESSA, FL 33556 US Other 510(k) Applications for this Company
Contact	WAYNE GLOVER 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	08/06/2014
Decision Date	06/03/2015
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