FDA 510(k) Application Details - K132138

Device Classification Name	More FDA Info for this Device
510(K) Number	K132138
Device Name	RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
Applicant	RHYTHMLINK INTERNATIONAL, LLC 1140 FIRST STREET SOUTH COLUMBIA, SC 29209 US Other 510(k) Applications for this Company
Contact	JAMES M MEWBORNE 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	07/11/2013
Decision Date	04/11/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review