Cleared Traditional

K903816 - URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
(FDA 510(k) Clearance)

K903816 · Respiratory Support Products, Inc. · Gastroenterology & Urology device
Oct 1990
Decision
72d
Days
Class 2
Risk

K903816 is an FDA 510(k) clearance for the URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR. This device is classified as a Catheter, Retention Type (Class II - Special Controls, product code EZK).

Submitted by Respiratory Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on October 31, 1990, 72 days after receiving the submission on August 20, 1990.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K903816 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 20, 1990
Decision Date October 31, 1990
Days to Decision 72 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EZK — Catheter, Retention Type
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.5980