BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015— 510(k) K023039

Name: FDA 510(k) clearance K023039
Creator: U.S. Food and Drug Administration
Published: 2002-11-07

Substantially Equivalent

Tuta Healthcare Pty Limited

FDA 510(k) clearance K023039 for BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015, Substantially Equivalent on 2002-11-07. Applicant: Tuta Healthcare Pty Limited. Device class: 2.

Clearance details

Applicant: Tuta Healthcare Pty Limited
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2002-09-12
Decision date: 2002-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney Nsw, AU

Download summary PDF View on FDA.gov ↗

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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.