FDA 510(k) Application Details - K162460

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K162460
Device Name	Electrode, Cutaneous
Applicant	WAVI, CO 3535 S IRVING ST. ENGLEWOOD, CO 80110 US Other 510(k) Applications for this Company
Contact	ALEXIS VERACRUZ 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	09/02/2016
Decision Date	04/28/2017
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