BLOOD & PLASMA ADMIN. DEV-STERILE— 510(k) K840411

Substantially Equivalent

Loversan

FDA 510(k) clearance K840411 for BLOOD & PLASMA ADMIN. DEV-STERILE, Substantially Equivalent on 1984-03-19. Applicant: Loversan.

Clearance details

Applicant: Loversan
Product code: Code BRZ
Advisory panel: General Hospital
Date received: 1984-01-31
Decision date: 1984-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.