Dantec Da Capo
FDA 510(k) K953999 · Dantec Medical, Inc.
510(k) numberK953999
Submission
- Device name
- Dantec Da Capo
- Applicant
- Dantec Medical, Inc.
Allendale, NJ, US - Received
- August 24, 1995
- Decision date
- November 21, 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
| 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 |
| 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 |
| K900770 | Home Urodata System(Tm)EXY · Traditional | Biodan Medical Systems, Ltd. | 06/08/1990SE |
More from Biodan Medical Systems, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K960503 | Dantec DuetFEN · Traditional | 09/16/1996SE |
| K950314 | Dantec Monopolar Lumen Electrode (13R18 and 13R19)GXZ · Traditional | 03/25/1996SE |
| K926363 | Multi-Dop SIYO · Traditional | 06/19/1995SE |
| K931801 | Multi-Dop XIYO · Traditional | 06/14/1995SE |
| K930458 | Multi-Dop LIYN · Traditional | 02/03/1995SE |
| K932059 | Needle Electrodes and Disposable Scalp ElectrodeIKT · Traditional | 10/04/1994SE |
| K934580 | Dantec 13R45 Bar ElectrodeGXY · Traditional | 09/26/1994SE |
| K931966 | Dantec Disposable Concentric NeedleIKT · Traditional | 03/30/1994SE |
| K931923 | Dantec Maglite Magnetic Stimulator (Maglite)GWF · Traditional | 11/09/1993SE |
| K926516 | Dantec Magnetic Stimulator MagproGWF · Traditional | 08/31/1993SE |
Questions and answers
When was Dantec Da Capo cleared by the FDA?
Dantec Da Capo (K953999) received a 510(k) decision of Substantially Equivalent on November 21, 1995, 89 days after the submission was received.
What is the product code of K953999?
The FDA product code is EXY – Uroflowmeter, a Class II (moderate risk) device regulated under 21 CFR 876.1800.