SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL— 510(k) K024247

Substantially Equivalent

Leonhard Lang GmbH

FDA 510(k) clearance K024247 for SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL, Substantially Equivalent on 2003-01-16. Applicant: Leonhard Lang GmbH.

Clearance details

Applicant: Leonhard Lang GmbH
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 2002-12-23
Decision date: 2003-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Stillwater, MN, US

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.