4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION— 510(k) K945495

Name: FDA 510(k) clearance K945495
Creator: U.S. Food and Drug Administration
Published: 1995-02-09

Substantially Equivalent

Fiberoptic Sensor Technlogies, Inc.

FDA 510(k) clearance K945495 for 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION, Substantially Equivalent on 1995-02-09. Applicant: Fiberoptic Sensor Technlogies, Inc.. Device class: 2.

Clearance details

Applicant: Fiberoptic Sensor Technlogies, Inc.
Product code: Code EXY
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1994-11-08
Decision date: 1995-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXY

view all

K142425 — Uroflowmeter2014-10-27
K022721 — UROPOWER2003-08-26
K971913 — GR100F URINE FLOWMETER1997-09-19
K953999 — DANTEC DA CAPO1995-11-21
K951442 — FLOLAB1995-08-24

More clearances from Fiberoptic Sensor Technlogies, Inc.

view all

K945753 — FST FIBEROPTIC PRESSURE CONVERTER1995-05-11
K950908 — FST CATH-UD, CATHETER1995-04-07
K930171 — FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR1993-11-04
K922476 — URO-PRO 20001993-07-20
K922776 — FST COUNCIL TIP FOLEY CATHETER1993-07-20

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