K945495 is an FDA 510(k) clearance for the 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION. This device is classified as a Uroflowmeter (Class II - Special Controls, product code EXY).
Submitted by Fiberoptic Sensor Technlogies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on February 9, 1995, 93 days after receiving the submission on November 8, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.
| 510(k) Number | K945495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1994 |
| Decision Date | February 09, 1995 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EXY — Uroflowmeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1800 |