ULTRAEKOGEL MODELS EK 2000 & EK 2001— 510(k) K030889

Name: FDA 510(k) clearance K030889
Creator: U.S. Food and Drug Administration
Published: 2003-05-23

Substantially Equivalent

Inmed Ltda.

FDA 510(k) clearance K030889 for ULTRAEKOGEL MODELS EK 2000 & EK 2001, Substantially Equivalent on 2003-05-23. Applicant: Inmed Ltda.. Device class: 2.

Clearance details

Applicant: Inmed Ltda.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2003-03-21
Decision date: 2003-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUI

view all

K253255 — Non-Sterile Ultrasound Gel Sterile Ultrasound Gel2026-06-17
K252337 — EdgeFlow Gel Pad2026-04-24
K242167 — Sterile and Non-Sterile Ultrasonic Coupling Agent2024-09-19
K241789 — Non-Sterile Ultrasound Transmission Gels2024-07-24
K232957 — Sterile and Non-Sterile Ultrasound Gels2023-12-15

More clearances from Inmed Ltda.

view all

K030081 — CSF400 AND CSF6002003-10-06
K030887 — LEKTROGEL, MODEL LK30012003-06-13

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