4-CHANNEL Urodynamic Monitor with Uro-Flo Option
FDA 510(k) K945495 · Fiberoptic Sensor Technlogies, Inc.
510(k) numberK945495
Submission
- Device name
- 4-CHANNEL Urodynamic Monitor with Uro-Flo Option
- Applicant
- Fiberoptic Sensor Technlogies, Inc.
Ann Arbor, MI, US - Received
- November 8, 1994
- Decision date
- February 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EXY – Uroflowmeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1800
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EXY
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|---|---|---|---|
| K142425 | UroflowmeterEXY · Traditional | Be Technologies, Inc. | 10/27/2014SE |
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| K971913 | GR100F Urine FlowmeterEXY · Traditional | Albyn Medical , Ltd. | 09/19/1997SE |
| K953999 | Dantec Da CapoEXY · Traditional | Dantec Medical, Inc. | 11/21/1995SE |
| K951442 | FlolabEXY · Traditional | Synectics Medical, Inc. | 08/24/1995SE |
| K944972 | Uro-Gram Cystomrtrogram with UroflowmetryEXY · Traditional | Myo/Kinetic Systems, Inc. | 03/08/1995SE |
| K941105 | Uorcap,Model Number Uds-UcapEXY · Traditional | Laborie Medical Tech, Inc. | 05/10/1994SE |
| K904557 | MicrofloEXY · Traditional | Life-Tech Intl., Inc. | 12/28/1990SE |
| K902408 | Diagnostic Ultrasound Ufs 1005EXY · Traditional | Diagnostic Ultrasound Corp. | 08/10/1990SE |
| K900770 | Home Urodata System(Tm)EXY · Traditional | Biodan Medical Systems, Ltd. | 06/08/1990SE |
More from Biodan Medical Systems, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K945753 | FST Fiberoptic Pressure ConverterFEN · Traditional | 05/11/1995SE |
| K950908 | FST Cath-Ud, CatheterFEN · Traditional | 04/07/1995SE |
| K930171 | FST Dual, Dual Pressure Urodynamics MonitorFEN · Traditional | 11/04/1993SE |
| K922776 | FST Council Tip Foley CatheterFEN · Traditional | 07/20/1993SE |
| K922476 | Uro-Pro 2000FAP · Traditional | 07/20/1993SE |
| K926088 | FST Cath Ud-Dual Dual Pressure CatheterFEN · Traditional | 06/18/1993SE |
| K913113 | FST Cath-Ud Catheter, ModificationFEN · Traditional | 10/09/1991SE |
| K913721 | FST Cath - Ui Usrodynamic Cath Introducer SystemFEN · Traditional | 10/08/1991SE |
| K905641 | FST Cath-Ud CatheterFEN · Traditional | 02/19/1991SE |
| K864000 | FST Disposable Fiber Optic Transducer #0100-00DXO · Traditional | 01/16/1987SE |
Questions and answers
When was 4-CHANNEL Urodynamic Monitor with Uro-Flo Option cleared by the FDA?
4-CHANNEL Urodynamic Monitor with Uro-Flo Option (K945495) received a 510(k) decision of Substantially Equivalent on February 9, 1995, 93 days after the submission was received.
What is the product code of K945495?
The FDA product code is EXY – Uroflowmeter, a Class II (moderate risk) device regulated under 21 CFR 876.1800.