WSP CODE 4300 DIOMASTER DIAGNOSTIC— 510(k) K850696

Name: FDA 510(k) clearance K850696
Creator: U.S. Food and Drug Administration
Published: 1985-05-17

Substantially Equivalent

Warne Surgical Products, Ltd.

FDA 510(k) clearance K850696 for WSP CODE 4300 DIOMASTER DIAGNOSTIC, Substantially Equivalent on 1985-05-17. Applicant: Warne Surgical Products, Ltd.. Device class: 2.

Clearance details

Applicant: Warne Surgical Products, Ltd.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1985-02-21
Decision date: 1985-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armagh Bt66 8rd, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAP

view all

K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE2012-12-13
K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE1998-02-19
K963330 — URODYNAMIC ANALYSIS MODULE1997-04-03
K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER1996-08-27
K931175 — SCHUSTER DISPOSABLE BALLOON PROBE1994-04-01

More clearances from Warne Surgical Products, Ltd.

view all

K850694 — WSP CODE 4310 STRESSCATH1985-05-17
K850695 — WSP CODE 4301 DIOMASTER THERAPEUTIC1985-05-16
K850693 — WSP CODE 4315 PADTEST1985-05-10
K841511 — HAEMATURIA CATHETERS1984-07-12
K840687 — KIDNEY TRANSPLANT CATHETER1984-06-07

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