EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE— 510(k) K080587

Name: FDA 510(k) clearance K080587
Creator: U.S. Food and Drug Administration
Published: 2008-05-15

Substantially Equivalent

Animas Corp.

FDA 510(k) clearance K080587 for EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE, Substantially Equivalent on 2008-05-15. Applicant: Animas Corp.. Device class: 2.

Clearance details

Applicant: Animas Corp.
Product code: Code MRZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2008-03-03
Decision date: 2008-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.