FDA 510(k) Application Details - K162383

Device Classification Name	Electromyograph, Diagnostic   More FDA Info for this Device
510(K) Number	K162383
Device Name	Electromyograph, Diagnostic
Applicant	CADWELL INDUSTRIES, INC. 909 NORTH KELLOGG STREET KENNEWICK, WA 99336 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER BOLKAN Other 510(k) Applications for this Contact
Regulation Number	890.1375   More FDA Info for this Regulation Number
Classification Product Code	IKN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2016
Decision Date	03/01/2017
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