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 |
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