FDA 510(k) Application Details - K162459

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K162459
Device Name	Electrode, Depth
Applicant	MICROPROBES FOR LIFE SCIENCE, INC. DBA NEURON 18247-D FLOWER HILL WAY Gaithersburg, MD 20879 US Other 510(k) Applications for this Company
Contact	Martin Bak 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	09/02/2016
Decision Date	06/15/2017
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