MX820-5 PRESSURE INFUSOR 500CC MX820-10— 510(k) K800560

Name: FDA 510(k) clearance K800560
Creator: U.S. Food and Drug Administration
Published: 1980-04-29

Substantially Equivalent

Medex, Inc.

FDA 510(k) clearance K800560 for MX820-5 PRESSURE INFUSOR 500CC MX820-10, Substantially Equivalent on 1980-04-29. Applicant: Medex, Inc.. Device class: 1.

Clearance details

Applicant: Medex, Inc.
Product code: Code KZD
Device class: Class 1
Regulation: 21 CFR 880.5420
Advisory panel: General Hospital
Date received: 1980-03-12
Decision date: 1980-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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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.