Home Urodata System(Tm)
FDA 510(k) K900770 · Biodan Medical Systems, Ltd.
510(k) numberK900770
Submission
- Device name
- Home Urodata System(Tm)
- Applicant
- Biodan Medical Systems, Ltd.
Israel, IL - Received
- February 16, 1990
- Decision date
- June 8, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142425 | UroflowmeterEXY · Traditional | Be Technologies, Inc. | 10/27/2014SE |
| K022721 | UropowerEXY · Traditional | W.O.M. World of Medicine AG | 08/26/2003SE |
| 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 |
| K945495 | 4-CHANNEL Urodynamic Monitor with Uro-Flo OptionEXY · Traditional | Fiberoptic Sensor Technlogies, Inc. | 02/09/1995SE |
| 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 |
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| K930262 | Treatment Table, Model #825-100INO · Traditional | 03/29/1993SE |
| K930259 | Traction Table Model #825-200JFB · Traditional | 03/24/1993SE |
| K926083 | Nuclear Patient Sanning Tables, Various TypesIYX · Traditional | 02/12/1993SE |
| K926082 | Cardiac Stress Table, 056-180/UNIV Roll Stress AttIZI · Traditional | 12/30/1992SE |
| K922591 | Urological C-Arm Table, Model #056-450IXR · Traditional | 11/27/1992SE |
| K922605 | Trendelenburg Ultrasound Table, Model # 056-603IYO · Traditional | 10/20/1992SE |
| K922604 | Deluxe Adjustable Height Ultrasound TableIYO · Traditional | 10/20/1992SE |
| K923350 | Closed Chain Attachment, Model #820-520IKK · Traditional | 07/23/1992SE |
Questions and answers
When was Home Urodata System(Tm) cleared by the FDA?
Home Urodata System(Tm) (K900770) received a 510(k) decision of Substantially Equivalent on June 8, 1990, 112 days after the submission was received.
What is the product code of K900770?
The FDA product code is EXY – Uroflowmeter, a Class II (moderate risk) device regulated under 21 CFR 876.1800.