PRESSURE INFUSION PUMP— 510(k) K813105

Substantially Equivalent

Calbio, Inc.

FDA 510(k) clearance K813105 for PRESSURE INFUSION PUMP, Substantially Equivalent on 1981-12-14. Applicant: Calbio, Inc..

Clearance details

Applicant: Calbio, Inc.
Product code: Code KZD
Advisory panel: General Hospital
Date received: 1981-11-03
Decision date: 1981-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.