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

Substantially Equivalent

Medex, Inc.

Clearance details

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

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.