K860368 is an FDA 510(k) clearance for the URDYN 5000 (UROFLOWMETER). This device is classified as a Retractor, Self-retaining (Class I - General Controls, product code FFO).
Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on April 23, 1986, 79 days after receiving the submission on February 3, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K860368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1986 |
| Decision Date | April 23, 1986 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FFO — Retractor, Self-retaining |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4730 |