FDA 510(k) Application Details - K002043

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K002043
Device Name	Perineometer
Applicant	PURDUE TECHNOLOGY PARK 3000 KENT AVE. SUITE D1-113 WEST LAFAYETTE, IN 47906 US Other 510(k) Applications for this Company
Contact	CHRISTOPH WEISMAYER 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	07/05/2000
Decision Date	05/21/2001
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