SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21— 510(k) K041883

Name: FDA 510(k) clearance K041883
Creator: U.S. Food and Drug Administration
Published: 2004-09-07

Substantially Equivalent

Leonhard Lang GmbH

FDA 510(k) clearance K041883 for SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21, Substantially Equivalent on 2004-09-07. Applicant: Leonhard Lang GmbH. Device class: 3.

Clearance details

Applicant: Leonhard Lang GmbH
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2004-07-12
Decision date: 2004-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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K142803 — Skintact, various other tradenames2014-12-02
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K103186 — SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES2011-02-08
K092291 — SKINTACT AND VARIOUS OTHER TRADENAMES2009-08-21

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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