FDA 510(k) Application Details - K240805

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K240805
Device Name	Perineometer
Applicant	Pelvital USA, Inc. 860 Blue Gentian Road Suite 200 Eagan, MN 55121 US Other 510(k) Applications for this Company
Contact	Lydia Zeller 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	03/25/2024
Decision Date	08/01/2024
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