Uritron Urine Meter

FDA 510(k) K790894 · Joseph F. Daniel, C.R.N.A.

Substantially Equivalent

510(k) numberK790894

Submission

Device name
Uritron Urine Meter
Applicant
Joseph F. Daniel, C.R.N.A.
Mchenry, IL, US
Received
May 8, 1979
Decision date
September 7, 1979
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
K833043UrometerFFG · Traditional Browne Medical, Inc.02/04/1984SE
K813641Vital Metrics Urine Monitoring SystemFFG · Traditional Vital Metrics, Inc.03/01/1982SE

Questions and answers

When was Uritron Urine Meter cleared by the FDA?

Uritron Urine Meter (K790894) received a 510(k) decision of Substantially Equivalent on September 7, 1979, 122 days after the submission was received.

What is the product code of K790894?

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.