Diagnostic Ultrasound/Uro-Gyn Ups 2020
FDA 510(k) K911125 · Diagnostic Ultrasound Corp.
510(k) numberK911125
Submission
- Device name
- Diagnostic Ultrasound/Uro-Gyn Ups 2020
- Applicant
- Diagnostic Ultrasound Corp.
Kirkland, WA, US - Received
- March 13, 1991
- Decision date
- August 15, 1991
- 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 |
|---|---|---|
| K030763 | Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemIYO · Traditional | 03/26/2003SE |
| K022153 | Bladderscan Bvi 6100IYO · Traditional | 08/15/2002SE |
| K982568 | Bladdermanager Pci 5000 Model 1002ITX · Traditional | 01/25/1999SE |
| K963585 | Bladder Manager Pci 5000, Bladderscan Bvi 5000IYO · Traditional | 10/01/1996SE |
| K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000IYO · Traditional | 05/24/1996SE |
| K955942 | Bladderscan Bvi 5000IYO · Traditional | 03/15/1996SE |
| K920664 | Diagnostic Ultrasound/Uro-Gyn Ups 2020, Gi VersionFFX · Traditional | 12/23/1993SE |
| K915342 | Ud 2000 Video OptionLLZ · Traditional | 06/10/1992SE |
| K915436 | Bladderscan Bvi 2500IYO · Traditional | 03/03/1992SE |
| K911166 | Diagnostic Ultrasound/Uro-Gyn Ud 511DXT · Traditional | 08/15/1991SE |
Questions and answers
When was Diagnostic Ultrasound/Uro-Gyn Ups 2020 cleared by the FDA?
Diagnostic Ultrasound/Uro-Gyn Ups 2020 (K911125) received a 510(k) decision of Substantially Equivalent on August 15, 1991, 155 days after the submission was received.
What is the product code of K911125?
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.