Profile Urodynamic Monitoring Sys

FDA 510(k) K834503 · Browne Medical, Inc.

Substantially Equivalent

510(k) numberK834503

Submission

Device name
Profile Urodynamic Monitoring Sys
Applicant
Browne Medical, Inc.
Walker, MI, US
Received
December 21, 1983
Decision date
February 21, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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)DeviceApplicantDecision
K113771Signal Gear Urethral Catheter ElectrodeFAP · Traditional Neurovision Medical Products, Inc.12/13/2012SE
K974775Single Channel Urological Pressure Gauge, Dual Channel Urological Pressure GaugeFAP · Traditional Airtronic Services, Inc.02/19/1998SE
K963330Urodynamic Analysis ModuleFAP · Traditional Synectics Medical, Inc.04/03/1997SE
K962472Rusch Urodynamic Rectal Balloon 2-WAY CatheterFAP · Traditional Rusch Intl.08/27/1996SE
K931175Schuster Disposable Balloon ProbeFAP · Traditional Sandhill Scientific, Inc.04/01/1994SE
K931179Urolab SpectrumFAP · Traditional Life-Tech Intl., Inc.11/18/1993SE
K922476Uro-Pro 2000FAP · Traditional Fiberoptic Sensor Technlogies, Inc.07/20/1993SE
K924383Synectics Liberty System, PC Polygraf/Polygram UroFAP · Traditional Synectics-Dantec06/18/1993SE
K923995Urodynamics Tubing Kits #5161, #5150, #7170FAP · Traditional Advanced Medical Products, Inc.04/08/1993SE
K923464Urodynamic CathetersFAP · Traditional R.L. Medical Corp.02/05/1993SE

More from R.L. Medical Corp.

510(k)DeviceDecision
K851483Urobei Stress Incontinence MonitorFAP · Traditional 08/07/1985SE
K833043UrometerFFG · Traditional 02/04/1984SE
K830221Bedside N.P.T. 9900 - Printer 9800LIL · Traditional 03/17/1983SE

Questions and answers

When was Profile Urodynamic Monitoring Sys cleared by the FDA?

Profile Urodynamic Monitoring Sys (K834503) received a 510(k) decision of Substantially Equivalent on February 21, 1984, 62 days after the submission was received.

What is the product code of K834503?

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.