LUMAX (MODIFICATION)— 510(k) K954093

Substantially Equivalent

Medamicus, Inc.

FDA 510(k) clearance K954093 for LUMAX (MODIFICATION), Substantially Equivalent on 1996-01-11. Applicant: Medamicus, Inc.. Device class: 2.

Clearance details

Applicant: Medamicus, Inc.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1995-08-09
Decision date: 1996-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FEN

K212830 — CT3000Pro2021-12-21
K082701 — URONIRS, MODEL 20002008-12-18
K073552 — LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY2008-03-05
K001386 — ACCUSET SENSOR, MODEL 20002000-07-17
K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E01012000-02-28

More clearances from Medamicus, Inc.

K040150 — MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER2004-02-18
K030905 — MEDAMICUS FLOWGUARD PEELABLE INTRODUCER2003-04-09
K022689 — MODIFICATION TO MEDAMICUS AXIA RSN2002-08-23
K021004 — VALVED PEELABLE INTRODUCER2002-06-06
K020563 — MEDAMICUS AXIA RSN2002-05-21

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