FDA 510(k) Applications for Medical Device Product Code: FEN (Device, Cystometric, Hydraulic)

FDA 510(k) Applications for Medical Device Product Code "FEN"
(Device, Cystometric, Hydraulic)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K964522	ANDROMEDA MEDIZINISCHE SYSTEME GMBH	ELLIPSE 4	03/21/1997
K970595	CIRCON VIDEO	CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP	10/24/1997
K960503	DANTEC MEDICAL, INC.	DANTEC DUET	09/16/1996
K983325	INFLUENCE, INC.	IN-PROBE II URODYNAMIC SYSTEM	11/24/1998
K073552	LABORIE MEDICAL TECHNOLOGIES, CORP	LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY	03/05/2008
K954093	MEDAMICUS, INC.	LUMAX (MODIFICATION)	01/11/1996
K971911	MEDAMICUS, INC.	LUMAX CYSTOMETRY ADMINISTRATION TUBE SET	06/03/1997
K953734	MEDAMICUS, INC.	LUMAX(MODIFICATION)	01/18/1996
K992715	MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S	NEURO URODYNAMIC SUITE, MODEL 9032E0101	02/28/2000
K001386	PELVICARE, INC.	ACCUSET SENSOR, MODEL 2000	07/17/2000
K212830	SRS Medical	CT3000Pro	12/21/2021
K082701	URODYNAMIX TECHNOLOGIES LTD	URONIRS, MODEL 2000	12/18/2008