DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020— 510(k) K911125

Name: FDA 510(k) clearance K911125
Creator: U.S. Food and Drug Administration
Published: 1991-08-15

Substantially Equivalent

Diagnostic Ultrasound Corp.

FDA 510(k) clearance K911125 for DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, Substantially Equivalent on 1991-08-15. Applicant: Diagnostic Ultrasound Corp.. Device class: 2.

Clearance details

Applicant: Diagnostic Ultrasound Corp.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1991-03-13
Decision date: 1991-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, WA, US

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 Diagnostic Ultrasound Corp.

view all

K030763 — DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM2003-03-26
K022153 — BLADDERSCAN BVI 61002002-08-15
K982568 — BLADDERMANAGER PCI 5000 MODEL 10021999-01-25
K963585 — BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 50001996-10-01
K955840 — BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 50001996-05-24

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