Uroflowmeter— 510(k) K142425

Substantially Equivalent

Be Technologies, Inc.

FDA 510(k) clearance K142425 for Uroflowmeter, Substantially Equivalent on 2014-10-27. Applicant: Be Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Be Technologies, Inc.
Product code: Code EXY
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 2014-08-29
Decision date: 2014-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXY

K022721 — UROPOWER2003-08-26
K971913 — GR100F URINE FLOWMETER1997-09-19
K953999 — DANTEC DA CAPO1995-11-21
K951442 — FLOLAB1995-08-24
K944972 — URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY1995-03-08

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