K992715 is an FDA 510(k) clearance for the NEURO URODYNAMIC SUITE, MODEL 9032E0101. This device is classified as a Device, Cystometric, Hydraulic (Class II - Special Controls, product code FEN).
Submitted by Medtronic Functional Diagnostics A/S (Skovlunde, DK). The FDA issued a Cleared decision on February 28, 2000, 200 days after receiving the submission on August 12, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K992715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1999 |
| Decision Date | February 28, 2000 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEN — Device, Cystometric, Hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |