510(k) K053204— INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A

Substantially Equivalent

Draeger Medical AG & Co. Kgaa

Clearance details

Applicant: Draeger Medical AG & Co. Kgaa
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2005-11-16
Decision date: 2006-02-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Telford, PA, US

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.