K771561 is an FDA 510(k) clearance for the DOVER URINE METER. This device is classified as a Urinometer, Mechanical (Class II - Special Controls, product code EXR).
Submitted by Will Ross Co. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1977, 23 days after receiving the submission on August 15, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.
| 510(k) Number | K771561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1977 |
| Decision Date | September 07, 1977 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EXR — Urinometer, Mechanical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1800 |