510(k) K213191— S-Line

Substantially Equivalent

Barkey GmbH & Co. KG

Clearance details

Applicant: Barkey GmbH & Co. KG
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2021-09-29
Decision date: 2022-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leopoldshoehe, DE

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.