FDA 510(k) Application Details - K132588

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K132588
Device Name	Electrode, Cutaneous
Applicant	TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. P.O. BOX 120-119 SHANGHAI 200120 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	08/19/2013
Decision Date	11/22/2013
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