K841561

Substantially Equivalent

HESUNG'S BLOOD DONOR SETS

Applicant: Amkor Trading Co.
Product code: BRZ
Advisory panel: General Hospital
Date received: 1984-07-13
Decision date: 1984-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MD, US

Adverse events under product code BRZ

product code BRZ

Malfunction: 458
Total: 458

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.