EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE— 510(k) K063674

Name: FDA 510(k) clearance K063674
Creator: U.S. Food and Drug Administration
Published: 2007-03-30

Substantially Equivalent

Animas Corp.

FDA 510(k) clearance K063674 for EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE, Substantially Equivalent on 2007-03-30. Applicant: Animas Corp.. Device class: 2.

Clearance details

Applicant: Animas Corp.
Product code: Code LZG
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2006-12-11
Decision date: 2007-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

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.