Urostresstik Diagnostic Cystometry Pack
FDA 510(k) K844503 · Epcom Medical Systems, Inc.
510(k) numberK844503
Submission
- Device name
- Urostresstik Diagnostic Cystometry Pack
- Applicant
- Epcom Medical Systems, Inc.
Hayward, CA, US - Received
- November 20, 1984
- Decision date
- January 2, 1985
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K910518 | Glove-N-Gel Amniotomy KitHGE · Traditional | 05/09/1991SESK |
| K905812 | Intrauterine Catheter SetHGS · Traditional | 01/31/1991SE |
| K881414 | CervicathHDR · Traditional | 06/14/1988SE |
| K871079 | Fetalflex Fetal ElectrodeHGP · Traditional | 07/13/1987SE |
| K844338 | 1URO-LOG Home Diagnostic PackFFG · Traditional | 02/25/1985SE |
| K841805 | Obstetrical DopplerKNG · Traditional | 06/19/1984SE |
| K831115 | Epcom EMS-320 Remote MonitorscopeHGM · Traditional | 08/12/1983SE |
| K831114 | Epcom EMS-330 Freedom I Teledop ObstetHGM · Traditional | 08/12/1983SE |
| K831113 | Epcom EMS-310 Intrapartum MonitorHGM · Traditional | 08/12/1983SE |
| K831112 | Epcom VCU-1 Vacuum System & CuretteHHI · Traditional | 06/30/1983SE |
Questions and answers
When was Urostresstik Diagnostic Cystometry Pack cleared by the FDA?
Urostresstik Diagnostic Cystometry Pack (K844503) received a 510(k) decision of Substantially Equivalent on January 2, 1985, 43 days after the submission was received.
What is the product code of K844503?
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.