FDA 510(k) Application Details - K123390

Device Classification Name	More FDA Info for this Device
510(K) Number	K123390
Device Name	PEDIGUARD NERVE DETECTOR SYSTEM
Applicant	SPINEGUARD, S.A. 555 13TH ST. NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JOHN J SMITH, M.D. J.D. Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2012
Decision Date	08/08/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review