FDA 510(k) Application Details - K121743

Device Classification Name	Stimulator, Nerve, Battery-Powered   More FDA Info for this Device
510(K) Number	K121743
Device Name	Stimulator, Nerve, Battery-Powered
Applicant	SUNMED LLC C/O EASYMED INSTRUMENTS CO,5/ -6/F,BLOCK A,GUPO GONGMAO BLDG FENGXIN RD, FENGXIANG INDUSTRIAL DISTRICT DALIANG, SHUNDE, FOSHAN 528300 CN Other 510(k) Applications for this Company
Contact	WU TINGJIE Other 510(k) Applications for this Contact
Regulation Number	868.2775   More FDA Info for this Regulation Number
Classification Product Code	BXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2012
Decision Date	03/28/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review