BOSTON BLOOD DONOR SETS— 510(k) K822410

Substantially Equivalent

The Boston Medical Group

FDA 510(k) clearance K822410 for BOSTON BLOOD DONOR SETS, Substantially Equivalent on 1982-09-30. Applicant: The Boston Medical Group.

Clearance details

Applicant: The Boston Medical Group
Product code: Code BRZ
Advisory panel: General Hospital
Date received: 1982-08-10
Decision date: 1982-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.