FDA 510(k) Application Details - K223884

Device Classification Name	More FDA Info for this Device
510(K) Number	K223884
Device Name	ELITONE Urge Urinary Incontinence Device
Applicant	Elidah Inc 810 Main St. Ste C Monroe, CT 06468 US Other 510(k) Applications for this Company
Contact	Gloria Kolb Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2022
Decision Date	02/24/2023
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