FDA 510(k) Application Details - K192603

Device Classification Name	Electrode, Needle   More FDA Info for this Device
510(K) Number	K192603
Device Name	Electrode, Needle
Applicant	Spes Medica S.r.l. Via Europa - zona industriale Battipaglia (SA) 84091 IT Other 510(k) Applications for this Company
Contact	Giorgio Facco Other 510(k) Applications for this Contact
Regulation Number	882.1350   More FDA Info for this Regulation Number
Classification Product Code	GXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2019
Decision Date	11/22/2019
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