FDA 510(k) Application Details - K180637

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K180637
Device Name	Perineometer
Applicant	Renovia Inc. 263 Summer St., 5th Floor Boston, MA 02210 US Other 510(k) Applications for this Company
Contact	Gina Prochillo-Cawston 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	03/12/2018
Decision Date	04/04/2018
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