FDA 510(k) Application Details - K110289

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K110289
Device Name	Electrode, Cutaneous
Applicant	XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. NO 9, GAO ZIN 1ST ROAD HI-TECH DEVELOPMENT ZONE XI'AN, SHAANXI 710075 CN Other 510(k) Applications for this Company
Contact	ZHAI YING CHUAN Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2011
Decision Date	08/30/2011
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