Neuro Urodynamic Suite, Model 9032E0101
FDA 510(k) K992715 · Medtronic Functional Diagnostics A/S
510(k) numberK992715
Submission
- Device name
- Neuro Urodynamic Suite, Model 9032E0101
- Applicant
- Medtronic Functional Diagnostics A/S
Skovlunde, DK - Received
- August 12, 1999
- Decision date
- February 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEN – Device, Cystometric, Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
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| K073552 | Laborie Urodynamic System with Tetra AccessoryFEN · Traditional | Laborie Medical Technologies, Corp. | 03/05/2008SE |
| K001386 | Accuset Sensor, Model 2000FEN · Traditional | Pelvicare, Inc. | 07/17/2000SE |
| K983325 | In-Probe II Urodynamic SystemFEN · Traditional | Influence, Inc. | 11/24/1998SE |
| K970595 | Circon Endotek OM-4 H2O Cystometry PumpFEN · Traditional | Circon Video | 10/24/1997SE |
| K971911 | Lumax Cystometry Administration Tube SetFEN · Traditional | Medamicus, Inc. | 06/03/1997SE |
| K964522 | Ellipse 4FEN · Traditional | Andromeda Medizinische Systeme GmbH | 03/21/1997SE |
| K960503 | Dantec DuetFEN · Traditional | Dantec Medical, Inc. | 09/16/1996SE |
| K953734 | Lumax(Modification)FEN · Traditional | Medamicus, Inc. | 01/18/1996SE |
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| K014269 | Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf Id…MYE · Traditional | 11/21/2002SE |
| K011471 | Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberFFX · Traditional | 11/08/2002SE |
| K002992 | Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,901…IKT · Traditional | 08/15/2001SE |
| K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry…FFX · Traditional | 08/10/2001SE |
| K010130 | Polygram 98 Esophageal Manometry Testing Application, Model 9043S0103FFX · Special | 02/07/2001SE |
| K000386 | Polygram 98 Anorectal Function Testing Application, Model 9043S0111FFX · Traditional | 05/05/2000SE |
| K992713 | Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models…FFX · Traditional | 11/10/1999SE |
| K991389 | Anorectal Manometry Suite, Model 9032S0201FFX · Traditional | 07/15/1999SE |
| K990375 | Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75IKT · Special | 03/09/1999SE |
| K981733 | Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111FFX · Traditional | 02/04/1999SE |
Questions and answers
When was Neuro Urodynamic Suite, Model 9032E0101 cleared by the FDA?
Neuro Urodynamic Suite, Model 9032E0101 (K992715) received a 510(k) decision of Substantially Equivalent on February 28, 2000, 200 days after the submission was received.
What is the product code of K992715?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.