HOME URODATA SYSTEM(TM)— 510(k) K900770

Name: FDA 510(k) clearance K900770
Creator: U.S. Food and Drug Administration
Published: 1990-06-08

Substantially Equivalent

Biodan Medical Systems, Ltd.

FDA 510(k) clearance K900770 for HOME URODATA SYSTEM(TM), Substantially Equivalent on 1990-06-08. Applicant: Biodan Medical Systems, Ltd.. Device class: 2.

Clearance details

Applicant: Biodan Medical Systems, Ltd.
Product code: Code EXY
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1990-02-16
Decision date: 1990-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

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 Biodan Medical Systems, Ltd.

view all

K932153 — THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME1993-09-07
K930261 — RTM REHABILITATION TREADMILL, MODEL #945-2001993-05-26
K930262 — TREATMENT TABLE, MODEL #825-1001993-03-29
K930259 — TRACTION TABLE MODEL #825-2001993-03-24
K926083 — NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES1993-02-12

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