FDA 510(k) Application Details - K992715

Device Classification Name	Device, Cystometric, Hydraulic   More FDA Info for this Device
510(K) Number	K992715
Device Name	Device, Cystometric, Hydraulic
Applicant	MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S 16-18 TONSBAKKEN SKOVLUNDE DK-2740 DK Other 510(k) Applications for this Company
Contact	ANN-CHRISTINE JONSSON Other 510(k) Applications for this Contact
Regulation Number	876.1620   More FDA Info for this Regulation Number
Classification Product Code	FEN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/1999
Decision Date	02/28/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review