FDA 510(k) Application Details - K141586

Device Classification Name	Probe, Radiofrequency Lesion   More FDA Info for this Device
510(K) Number	K141586
Device Name	Probe, Radiofrequency Lesion
Applicant	DIROS TECHNOLOGY, INC. 120 GIBSON DRIVE MARKHAM,ON L3R 2Z3 CA Other 510(k) Applications for this Company
Contact	GEORGE DARMOS Other 510(k) Applications for this Contact
Regulation Number	882.4725   More FDA Info for this Regulation Number
Classification Product Code	GXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2014
Decision Date	12/30/2014
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