Rimeco Midstream Urine Collector

FDA 510(k) K943752 · Rimeco Products, Inc.

Substantially Equivalent

510(k) numberK943752

Submission

Device name
Rimeco Midstream Urine Collector
Applicant
Rimeco Products, Inc.
Oakwood Village, OH, US
Received
August 2, 1994
Decision date
November 1, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FOC – Bag, Urine Collection, Newborn
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5250
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FOC

510(k)DeviceApplicantDecision
K950176Premie U-Bag Urine Specimen CollectorFOC · Traditional Hollister, Inc.02/07/1995SE
K911329Bard(R) Surecatch Pediatric Urine Collect DeviceFOC · Traditional C.R. Bard, Inc.05/28/1991SE
K771368Portable Infant VentilatorFOC · Traditional Cavitron Corp.08/04/1977SE

Questions and answers

When was Rimeco Midstream Urine Collector cleared by the FDA?

Rimeco Midstream Urine Collector (K943752) received a 510(k) decision of Substantially Equivalent on November 1, 1994, 91 days after the submission was received.

What is the product code of K943752?

The FDA product code is FOC – Bag, Urine Collection, Newborn, a Class II (moderate risk) device regulated under 21 CFR 876.5250.