FFG — Device, Urine Flow Rate Measuring, Non-Electrical, Disposable Class II
FDA product code FFG covers "Device, Urine Flow Rate Measuring, Non-Electrical, Disposable", a Class II medical device regulated under 21 CFR 876.1800. Submissions are reviewed by the Gastroenterology, Urology panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FFG
- 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 |
|---|---|---|---|
| K893827 | laytech medical | PEAK FLOW RATE METER | August 11, 1989 |
| K883274 | medical engineering | SURGITEK (R) UROFLOW SYSTEM | February 8, 1989 |
| K850169 | eris medical technology | ERIS URO-DIAGNOSTIC SYSTEM | April 22, 1985 |
| K844338 | epcom medical systems | 1URO-LOG HOME DIAGNOSTIC PACK | February 25, 1985 |
| K843441 | vital metrics | URINARY DRAINAGE CONTAINER 2012-WITH | January 3, 1985 |
| K843442 | vital metrics | URINARY DRAINAGE CONTAINER 2013 WITH | January 3, 1985 |
| K844030 | travenol laboratories | ACCUMETER ELECTRONIC URINEMETER SYSTEM | November 20, 1984 |
| K843224 | life-tech intl | UROPUMP MODEL 1711 | October 19, 1984 |
| K833043 | browne medical | UROMETER | February 4, 1984 |
| K813641 | vital metrics | VITAL METRICS URINE MONITORING SYSTEM | March 1, 1982 |
| K813082 | burron medical products | UREOFIX 500 URINE MEASURING SYSTEM | December 31, 1981 |
| K811925 | c.r. bard | UROFLOWMETER | September 8, 1981 |
| K790894 | joseph f. daniel, c.r.n.a | URITRON URINE METER | September 7, 1979 |
| K790365 | hewlett-packard | FLUID MEASUREMENT STAND | May 11, 1979 |
| K790663 | life-tech instruments | MODEL 1750 STANDING URINAL | April 24, 1979 |
| K781597 | time motion system | PM 2000 AUTOMATIC PATIENT CHAIR | September 27, 1978 |
| K771655 | kendall research center | CURITY PEAKOMETER | October 14, 1977 |