K896732 is an FDA 510(k) clearance for the UNOMETER 500. This device is classified as a Urinometer, Mechanical (Class II - Special Controls, product code EXR).
Submitted by Unoplast A/S (Denmark, DK). The FDA issued a Cleared decision on November 2, 1990, 337 days after receiving the submission on November 30, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.
| 510(k) Number | K896732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1989 |
| Decision Date | November 02, 1990 |
| Days to Decision | 337 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 |