FDA 510(k) Application Details - K122410

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K122410
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	MEDIRUNE CO, LTD 821 SAMIL PLAZA 837-26 YEUKSAM-DONG GANGNAM-GU 135-768 KR Other 510(k) Applications for this Company
Contact	YANG HO DONG Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2012
Decision Date	11/12/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review