Browne Model UD-4DE
FDA 510(k) K790478 · Browne Corp.
510(k) numberK790478
Submission
- Device name
- Browne Model UD-4DE
- Applicant
- Browne Corp.
Mchenry, IL, US - Received
- March 9, 1979
- Decision date
- June 1, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAP – Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113771 | Signal Gear Urethral Catheter ElectrodeFAP · Traditional | Neurovision Medical Products, Inc. | 12/13/2012SE |
| K974775 | Single Channel Urological Pressure Gauge, Dual Channel Urological Pressure GaugeFAP · Traditional | Airtronic Services, Inc. | 02/19/1998SE |
| K963330 | Urodynamic Analysis ModuleFAP · Traditional | Synectics Medical, Inc. | 04/03/1997SE |
| K962472 | Rusch Urodynamic Rectal Balloon 2-WAY CatheterFAP · Traditional | Rusch Intl. | 08/27/1996SE |
| K931175 | Schuster Disposable Balloon ProbeFAP · Traditional | Sandhill Scientific, Inc. | 04/01/1994SE |
| K931179 | Urolab SpectrumFAP · Traditional | Life-Tech Intl., Inc. | 11/18/1993SE |
| K922476 | Uro-Pro 2000FAP · Traditional | Fiberoptic Sensor Technlogies, Inc. | 07/20/1993SE |
| K924383 | Synectics Liberty System, PC Polygraf/Polygram UroFAP · Traditional | Synectics-Dantec | 06/18/1993SE |
| K923995 | Urodynamics Tubing Kits #5161, #5150, #7170FAP · Traditional | Advanced Medical Products, Inc. | 04/08/1993SE |
| K923464 | Urodynamic CathetersFAP · Traditional | R.L. Medical Corp. | 02/05/1993SE |
More from R.L. Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K792094 | Browne Model UA-6FAP · Traditional | 12/06/1979SE |
| K792093 | Browne Model GD-5FAP · Traditional | 12/06/1979SE |
| K792092 | Browne Model UD-4EFAP · Traditional | 12/06/1979SE |
| K792091 | Browne Model UD-4DFAP · Traditional | 12/06/1979SE |
| K792090 | Browne Model UD-4FAP · Traditional | 12/06/1979SE |
| K790754 | Browne Model CF-1 and CF-1GFAP · Traditional | 06/01/1979SE |
Questions and answers
When was Browne Model UD-4DE cleared by the FDA?
Browne Model UD-4DE (K790478) received a 510(k) decision of Substantially Equivalent on June 1, 1979, 84 days after the submission was received.
What is the product code of K790478?
The FDA product code is FAP – Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, a Class II (moderate risk) device regulated under 21 CFR 876.1620.