FDA 510(k) Application Details - K171798

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K171798
Device Name	Electrode, Cutaneous
Applicant	Media Plus, LLC 560 Sylvan Aveue, 3rd Floor Englewood Cliffs, NJ 07632 US Other 510(k) Applications for this Company
Contact	Rita Vacco 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	06/16/2017
Decision Date	06/01/2018
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