K971913 is an FDA 510(k) clearance for the GR100F URINE FLOWMETER. This device is classified as a Uroflowmeter (Class II - Special Controls, product code EXY).
Submitted by Albyn Medical , Ltd. (Dingwall, Ross-Shire, GB). The FDA issued a Cleared decision on September 19, 1997, 120 days after receiving the submission on May 22, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.
| 510(k) Number | K971913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1997 |
| Decision Date | September 19, 1997 |
| Days to Decision | 120 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 |