FDA 510(k) Application Details - K200293

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K200293
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	InMode Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit 2069200 IL Other 510(k) Applications for this Company
Contact	Amit Goren 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	02/05/2020
Decision Date	05/05/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review