FDA 510(k) Application Details - K121257

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K121257
Device Name	Stimulator, Nerve
Applicant	TECHNOMED EUROPE AMERIKALAAN 71 MAASTRICHT AIRPORT 6199 AE NL Other 510(k) Applications for this Company
Contact	PIERRE VREULS 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	04/26/2012
Decision Date	08/28/2012
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