HEMOTEC HEPCON/SYSTEM FOUR & FOUR P— 510(k) K820410

Substantially Equivalent

Hemotec, Inc.

FDA 510(k) clearance K820410 for HEMOTEC HEPCON/SYSTEM FOUR & FOUR P, Substantially Equivalent on 1982-04-09. Applicant: Hemotec, Inc..

Clearance details

Applicant: Hemotec, Inc.
Product code: Code LOX
Advisory panel: Cardiovascular
Date received: 1982-02-12
Decision date: 1982-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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.