ENGSTROM ELIZA + CO2 ANALYZER— 510(k) K890112

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K890112 for ENGSTROM ELIZA + CO2 ANALYZER, Substantially Equivalent on 1989-03-15. Applicant: Gambro, Inc..

Clearance details

Applicant: Gambro, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1989-01-11
Decision date: 1989-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, US

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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.