EXR — Urinometer, Mechanical Class II
FDA product code EXR covers "Urinometer, Mechanical", a Class II medical device regulated under 21 CFR 876.1800. Submissions are reviewed by the Gastroenterology, Urology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EXR
- Device Class
- Class II
- Regulation Number
- 876.1800
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K934142 | Key Medical Services | URINARY DRAINAGE BAG | May 17, 1994 |
| K935578 | Puritas Health Care | URINE METER | Dec 17, 1993 |
| K911258 | Kendall Healthcare Products Co. Div.Of Tyco Health | KENDALL PEDIATRIC URINE METER | Apr 25, 1991 |
| K896732 | Unoplast | UNOMETER 500 | Nov 2, 1990 |
| K870240 | Fraass Survival Systems | COMPRESS AND SKULLCAP, HEAD DRESSING | Feb 20, 1987 |
| K771561 | Will Ross | DOVER URINE METER | Sep 7, 1977 |
| K770939 | Brother Scientific Products | URINE TESTER, MODEL 701 | Jun 3, 1977 |
| K770423 | Brother Scientific Products | URINE TESTER, MODEL NO. 707 | Jun 3, 1977 |
| K761083 | C.R. Bard | BARD URINE METER W/ BAG | Jan 26, 1977 |