THE KENDALL URINARY OUTPUT MONITOR— 510(k) K852083

Name: FDA 510(k) clearance K852083
Creator: U.S. Food and Drug Administration
Published: 1985-09-20

Substantially Equivalent

The Kendal Co.

FDA 510(k) clearance K852083 for THE KENDALL URINARY OUTPUT MONITOR, Substantially Equivalent on 1985-09-20. Applicant: The Kendal Co.. Device class: 1.

Clearance details

Applicant: The Kendal Co.
Product code: Code FFO
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1985-05-13
Decision date: 1985-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FFO

view all

K993544 — SPACE-OR RETRACTOR1999-12-22
K870897 — KODNER ANAL PERIONEAL RETRACTOR1987-06-04
K860368 — URDYN 5000 (UROFLOWMETER)1986-04-23
K853119 — URODYN 10001985-10-04

More clearances from The Kendal Co.

view all

K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR2000-03-17
K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C1999-09-28
K991758 — MONOJECT INSULIN SYRINGE1999-06-14
K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET1997-04-23
K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP1995-04-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.