Image Pro Urodynamics Measuring Syst, Modification
FDA 510(k) K920991 · Browne Medical Systems, Inc.
510(k) numberK920991
Submission
- Device name
- Image Pro Urodynamics Measuring Syst, Modification
- Applicant
- Browne Medical Systems, Inc.
Minneapolis, MN, US - Received
- February 14, 1992
- Decision date
- April 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K921047 | Model 8100 Urodynamics Measuring SystemFAP · Traditional | 04/10/1992SE |
| K920992 | Profile Plus Urodynamics Measuring Syst, ModifiedFAP · Traditional | 04/10/1992SE |
| K910444 | Browne Medical Systems ImageproFAP · Traditional | 06/10/1991SE |
| K910371 | Urodynamic Measuring SystemFAP · Traditional | 05/15/1991SE |
| K910285 | Browne Medical Syst.Inc Stand-Alone Water PumpFAP · Traditional | 04/02/1991SE |
| K910217 | Minipro 8100 Urodynamic Measureing SystemFAP · Traditional | 04/02/1991SE |
Questions and answers
When was Image Pro Urodynamics Measuring Syst, Modification cleared by the FDA?
Image Pro Urodynamics Measuring Syst, Modification (K920991) received a 510(k) decision of Substantially Equivalent on April 10, 1992, 56 days after the submission was received.
What is the product code of K920991?
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.