K935578 is an FDA 510(k) clearance for the URINE METER. This device is classified as a Urinometer, Mechanical (Class II - Special Controls, product code EXR).
Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on December 17, 1993, 29 days after receiving the submission on November 18, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.
| 510(k) Number | K935578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1993 |
| Decision Date | December 17, 1993 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EXR — Urinometer, Mechanical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1800 |