FDA 510(k) Application Details - K112426

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K112426
Device Name	Stimulator, Nerve
Applicant	XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. JIANXIANG YUAN #209 BEI SI HU ZHONG RD HAIDIAN DIS., BEIJING 100083 CN Other 510(k) Applications for this Company
Contact	CHU XIAOAN Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2011
Decision Date	04/02/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review