ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000— 510(k) K921168

Substantially Equivalent

Allen Medical Systems, Inc.

FDA 510(k) clearance K921168 for ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000, Substantially Equivalent on 1993-04-21. Applicant: Allen Medical Systems, Inc..

Clearance details

Applicant: Allen Medical Systems, Inc.
Product code: Code KZD
Advisory panel: General Hospital
Date received: 1992-03-10
Decision date: 1993-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford Heights, OH, US

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Adverse events under product code KZD

product code KZD

Death: 4
Total: 4

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.