FDA 510(k) Application Details - K133348

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K133348
Device Name	Stimulator, Nerve
Applicant	SPES MEDICA S.R.L. VIA EUROPA-ZONA INDUSTRIALE BATTIPAGLIA 84091 IT Other 510(k) Applications for this Company
Contact	GIORGIO FACCO Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2013
Decision Date	11/21/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review