SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS— 510(k) K072233

Substantially Equivalent

Leonhard Lang GmbH

FDA 510(k) clearance K072233 for SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS, Substantially Equivalent on 2007-10-05. Applicant: Leonhard Lang GmbH.

Clearance details

Applicant: Leonhard Lang GmbH
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2007-08-10
Decision date: 2007-10-05
Decision: Substantially Equivalent
Clearance type: Special
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.