FDA 510(k) Application Details - K173815

Device Classification Name	Electrode, Needle, Diagnostic Electromyograph   More FDA Info for this Device
510(K) Number	K173815
Device Name	Electrode, Needle, Diagnostic Electromyograph
Applicant	Natus Manufacturing Limited IDA Business Park Gort H91 PD92 IE Other 510(k) Applications for this Company
Contact	Maria Connolly Other 510(k) Applications for this Contact
Regulation Number	890.1385   More FDA Info for this Regulation Number
Classification Product Code	IKT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2017
Decision Date	06/29/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review