FDA 510(k) Application Details - K140780

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K140780
Device Name	Perineometer
Applicant	REGULATORY INSIGHT, INC. 33 Golden Eagle Lane Littleton, CO 80127 US Other 510(k) Applications for this Company
Contact	Kevin Walls 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	03/28/2014
Decision Date	09/10/2014
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