K831788 is an FDA 510(k) clearance for the URODYNAMIC ANALYZER. This device is classified as a Sigmoidoscope, Rigid, Electrical (Class II - Special Controls, product code FAN).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 101 days after receiving the submission on June 3, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K831788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1983 |
| Decision Date | September 12, 1983 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FAN — Sigmoidoscope, Rigid, Electrical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |