FDA 510(k) Application Details - K153045

Device Classification Name	Stimulator, Nerve, Battery-Powered   More FDA Info for this Device
510(K) Number	K153045
Device Name	Stimulator, Nerve, Battery-Powered
Applicant	EASYMED INSTRUMENT CO., LTD. 5/F-6/F, BLK A, GUPO GONGMAO BLD FENGXIN ROAD, FENGXIANG INDUSTRIAL DISTRICT DALIANG, SHUNDE, FOSHAN 528300 CN Other 510(k) Applications for this Company
Contact	Jeffery Wu (Tingjie Wu) 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	10/19/2015
Decision Date	05/13/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review