FDA 510(k) Application Details - K121347

Device Classification Name	Electrode, Needle   More FDA Info for this Device
510(K) Number	K121347
Device Name	Electrode, Needle
Applicant	RHYTHMLINK INTERNATIONAL, LLC 1140 FIRST ST. SOUTH COLUMBIA, SC 29209 US Other 510(k) Applications for this Company
Contact	JAMES MEWBORNE 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	05/01/2012
Decision Date	07/12/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review