K790936

Substantially Equivalent

MODEL 114 TREONIC H150 HAEMOHEATER

Applicant: Vickers America Medical Corp.
Product code: KZL
Advisory panel: Hematology
Date received: 1979-05-18
Decision date: 1979-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code KZL

product code KZL

Death: 3
Malfunction: 473
Total: 476

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.