Dantec Menuet
FDA 510(k) K896575 · Dantec Medical, Inc.
510(k) numberK896575
Submission
- Device name
- Dantec Menuet
- Applicant
- Dantec Medical, Inc.
Mahwah, NJ, US - Received
- November 20, 1989
- Decision date
- May 3, 1990
- 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 |
|---|---|---|
| K960503 | Dantec DuetFEN · Traditional | 09/16/1996SE |
| K950314 | Dantec Monopolar Lumen Electrode (13R18 and 13R19)GXZ · Traditional | 03/25/1996SE |
| K953999 | Dantec Da CapoEXY · Traditional | 11/21/1995SE |
| 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 |
Questions and answers
When was Dantec Menuet cleared by the FDA?
Dantec Menuet (K896575) received a 510(k) decision of Substantially Equivalent on May 3, 1990, 164 days after the submission was received.
What is the product code of K896575?
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.