FDA 510(k) Application Details - K201678

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K201678
Device Name	Electrode, Depth
Applicant	iCE Neurosystems, Inc. 1875 Connecticut Ave NW, Suite 12117 Washington, DC 20009 US Other 510(k) Applications for this Company
Contact	Allen Waziri Other 510(k) Applications for this Contact
Regulation Number	882.1330   More FDA Info for this Regulation Number
Classification Product Code	GZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2020
Decision Date	03/08/2021
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