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

Name: FDA 510(k) clearance K921168
Creator: U.S. Food and Drug Administration
Published: 1993-04-21

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.. Device class: 1.

Clearance details

Applicant: Allen Medical Systems, Inc.
Product code: Code KZD
Device class: Class 1
Regulation: 21 CFR 880.5420
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

Download summary PDF View on FDA.gov ↗

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K942933 — PRESSURE INFUSION CUFF1994-08-25

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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.