FDA 510(k) Application Details - K173571

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K173571
Device Name	Electrode, Cutaneous
Applicant	Infinite Biomedical Technologies, LLC 1101 E 33rd Street Suite E305 Baltimore, MD 21218 US Other 510(k) Applications for this Company
Contact	Rahul Kaliki 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	11/20/2017
Decision Date	03/21/2018
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