K911258 is an FDA 510(k) clearance for the KENDALL PEDIATRIC URINE METER. This device is classified as a Urinometer, Mechanical (Class II - Special Controls, product code EXR).
Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on April 25, 1991, 34 days after receiving the submission on March 22, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.
| 510(k) Number | K911258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1991 |
| Decision Date | April 25, 1991 |
| Days to Decision | 34 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 |