The following data is part of a premarket notification filed by Medtronic Functional Diagnostics A/s with the FDA for Neuro Urodynamic Suite, Model 9032e0101.
| Device ID | K992715 |
| 510k Number | K992715 |
| Device Name: | NEURO URODYNAMIC SUITE, MODEL 9032E0101 |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S 16-18 TONSBAKKEN Skovlunde, DK Dk-2740 |
| Contact | Ann-christine Jonsson |
| Correspondent | Ann-christine Jonsson MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S 16-18 TONSBAKKEN Skovlunde, DK Dk-2740 |
| Product Code | FEN |
| Subsequent Product Code | GWF |
| Subsequent Product Code | JXE |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-12 |
| Decision Date | 2000-02-28 |
| Summary: | summary |