FDA 510(k) Application Details - K121820

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K121820
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	ZYNEX MEDICAL, INC. 9990 Park Meadows Dr. Lone Tree, CO 80124 US Other 510(k) Applications for this Company
Contact	JIM ARNOLD Other 510(k) Applications for this Contact
Regulation Number	876.5320   More FDA Info for this Regulation Number
Classification Product Code	KPI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2012
Decision Date	08/24/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review