MAXONE IV FLUID/BLOOD WARMER, MODEL 102— 510(k) K023653

Name: FDA 510(k) clearance K023653
Creator: U.S. Food and Drug Administration
Published: 2003-01-17

Substantially Equivalent

Automatic Medical Technologies, Inc.

FDA 510(k) clearance K023653 for MAXONE IV FLUID/BLOOD WARMER, MODEL 102, Substantially Equivalent on 2003-01-17. Applicant: Automatic Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Automatic Medical Technologies, Inc.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2002-10-30
Decision date: 2003-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.