Uroflowmeter
FDA 510(k) K811925 · C.R. Bard, Inc.
510(k) numberK811925
Submission
- Device name
- Uroflowmeter
- Applicant
- C.R. Bard, Inc.
Warrendale, PA, US - Received
- July 2, 1981
- Decision date
- September 8, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1800
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893827 | Peak Flow Rate MeterFFG · Traditional | Laytech Medical Co. | 08/11/1989SE |
| K883274 | Surgitek (R) Uroflow SystemFFG · Traditional | Medical Engineering Corp. | 02/08/1989SE |
| K850169 | Eris Uro-Diagnostic SystemFFG · Traditional | Eris Medical Technology | 04/22/1985SE |
| K844338 | 1URO-LOG Home Diagnostic PackFFG · Traditional | Epcom Medical Systems, Inc. | 02/25/1985SE |
| K843442 | Urinary Drainage Container 2013 withFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K843441 | Urinary Drainage Container 2012-WITHFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K844030 | Accumeter Electronic Urinemeter SystemFFG · Traditional | Travenol Laboratories, S.A. | 11/20/1984SE |
| K843224 | Uropump Model 1711FFG · Traditional | Life-Tech Intl., Inc. | 10/19/1984SE |
| K833043 | UrometerFFG · Traditional | Browne Medical, Inc. | 02/04/1984SE |
| K813641 | Vital Metrics Urine Monitoring SystemFFG · Traditional | Vital Metrics, Inc. | 03/01/1982SE |
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Questions and answers
When was Uroflowmeter cleared by the FDA?
Uroflowmeter (K811925) received a 510(k) decision of Substantially Equivalent on September 8, 1981, 68 days after the submission was received.
What is the product code of K811925?
The FDA product code is FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.1800.