Cleared Traditional

K790663 - MODEL 1750 STANDING URINAL
(FDA 510(k) Clearance)

Apr 1979
Decision
18d
Days
Class 2
Risk

K790663 is an FDA 510(k) clearance for the MODEL 1750 STANDING URINAL. This device is classified as a Device, Urine Flow Rate Measuring, Non-electrical, Disposable (Class II - Special Controls, product code FFG).

Submitted by Life-Tech Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1979, 18 days after receiving the submission on April 6, 1979.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.

Submission Details

510(k) Number K790663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1979
Decision Date April 24, 1979
Days to Decision 18 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code FFG — Device, Urine Flow Rate Measuring, Non-electrical, Disposable
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.1800

Similar Devices — FFG Device, Urine Flow Rate Measuring, Non-electrical, Disposable

All 16
PEAK FLOW RATE METER
K893827 · Laytech Medical Co. · Aug 1989
SURGITEK (R) UROFLOW SYSTEM
K883274 · Medical Engineering Corp. · Feb 1989
ERIS URO-DIAGNOSTIC SYSTEM
K850169 · Eris Medical Technology · Apr 1985
1URO-LOG HOME DIAGNOSTIC PACK
K844338 · Epcom Medical Systems, Inc. · Feb 1985
URINARY DRAINAGE CONTAINER 2012-WITH
K843441 · Vital Metrics, Inc. · Jan 1985
URINARY DRAINAGE CONTAINER 2013 WITH
K843442 · Vital Metrics, Inc. · Jan 1985