FDA 510(k) Application Details - K122040

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K122040
Device Name	Stimulator, Nerve
Applicant	INVOTEC INTERNATIONAL, INC. 6833 PHILLIPS INDUSTRIAL BLVD. JACKSONVILLE, FL 32256-3029 US Other 510(k) Applications for this Company
Contact	JEFFREY L AULL 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	07/12/2012
Decision Date	10/31/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review