FDA 510(k) Application Details - K221476

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K221476
Device Name	Perineometer
Applicant	X6 Innovations 128 Rue De La BoΘtie Paris 75008 FR Other 510(k) Applications for this Company
Contact	Artem Rodionov Other 510(k) Applications for this Contact
Regulation Number	884.1425   More FDA Info for this Regulation Number
Classification Product Code	HIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2022
Decision Date	02/10/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review