Urometer

FDA 510(k) K833043 · Browne Medical, Inc.

Substantially Equivalent

510(k) numberK833043

Submission

Device name
Urometer
Applicant
Browne Medical, Inc.
Mchenry, IL, US
Received
September 6, 1983
Decision date
February 4, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1800
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FFG

510(k)DeviceApplicantDecision
K893827Peak Flow Rate MeterFFG · Traditional Laytech Medical Co.08/11/1989SE
K883274Surgitek (R) Uroflow SystemFFG · Traditional Medical Engineering Corp.02/08/1989SE
K850169Eris Uro-Diagnostic SystemFFG · Traditional Eris Medical Technology04/22/1985SE
K8443381URO-LOG Home Diagnostic PackFFG · Traditional Epcom Medical Systems, Inc.02/25/1985SE
K843442Urinary Drainage Container 2013 withFFG · Traditional Vital Metrics, Inc.01/03/1985SE
K843441Urinary Drainage Container 2012-WITHFFG · Traditional Vital Metrics, Inc.01/03/1985SE
K844030Accumeter Electronic Urinemeter SystemFFG · Traditional Travenol Laboratories, S.A.11/20/1984SE
K843224Uropump Model 1711FFG · Traditional Life-Tech Intl., Inc.10/19/1984SE
K813641Vital Metrics Urine Monitoring SystemFFG · Traditional Vital Metrics, Inc.03/01/1982SE
K813082Ureofix 500 Urine Measuring SystemFFG · Traditional Burron Medical Products, Inc.12/31/1981SE

More from Burron Medical Products, Inc.

510(k)DeviceDecision
K851483Urobei Stress Incontinence MonitorFAP · Traditional 08/07/1985SE
K834503Profile Urodynamic Monitoring SysFAP · Traditional 02/21/1984SE
K830221Bedside N.P.T. 9900 - Printer 9800LIL · Traditional 03/17/1983SE

Questions and answers

When was Urometer cleared by the FDA?

Urometer (K833043) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 151 days after the submission was received.

What is the product code of K833043?

The FDA product code is FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.1800.