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FDA 510(k)

EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE

K-Number: K080587 · 2008-05-15

ApplicantAnimas Corp.
Decision Date2008-05-15
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Animas Corp.. It received FDA 510(k) clearance on 2008-05-15 under 510(k) number K080587. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE?

EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE is a medical device that received FDA 510(k) clearance on 2008-05-15. The listed applicant is Animas Corp.. The 510(k) number is K080587.

When did EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE receive FDA 510(k) clearance?

EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE received FDA 510(k) clearance on 2008-05-15, under 510(k) number K080587.

Who is the listed applicant for EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE?

The FDA 510(k) record lists Animas Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE?

The FDA product code for EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE is MRZ.

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Other records listing Animas Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K080639SYMPHONY GLUCOSE MANAGEMENT SYSTEMK063674EZMANAGER MAX DIABETES MANAGEMENT SOFTWAREK042873ANIMAS MODEL IR1250 INSULIN INFUSION PUMPK032257MODEL IR 1200 INSULIN PUMPK022394EZMANAGER PLUSK021700ANIMUS EZSERTER INFUSION SET INSERTER

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Related Devices (Code: MRZ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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