SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES— 510(k) K103186

Substantially Equivalent

Leonhard Lang GmbH

FDA 510(k) clearance K103186 for SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES, Substantially Equivalent on 2011-02-08. Applicant: Leonhard Lang GmbH.

Clearance details

Applicant: Leonhard Lang GmbH
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2010-10-29
Decision date: 2011-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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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.