FDA 510(k) Application Details - K234061

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K234061
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	Fotona d.o.o. Stegne 7 Ljubljana SI Other 510(k) Applications for this Company
Contact	Tina Bartolic 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	12/22/2023
Decision Date	07/01/2024
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