FDA 510(k) Application Details - K222706

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K222706
Device Name	Electrode, Depth
Applicant	iCE Neurosystems, Inc. 1054 31st Street NW, Suite 300 Washington, DC 20007 US Other 510(k) Applications for this Company
Contact	Emir Kapetanovic 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	09/07/2022
Decision Date	12/06/2022
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