FDA 510(k) Application Details - K183123

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K183123
Device Name	Electrode, Depth
Applicant	FHC, Inc. 1201 Main Street Bowdoin, ME 04287 US Other 510(k) Applications for this Company
Contact	Kelly Moeykens 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	11/13/2018
Decision Date	12/20/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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