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FDA 510(k)

EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE

K-Number: K063674 · 2007-03-30

ApplicantAnimas Corp.
Decision Date2007-03-30
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZMANAGER 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 2007-03-30 under 510(k) number K063674. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE?

EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE is a medical device that received FDA 510(k) clearance on 2007-03-30. The listed applicant is Animas Corp.. The 510(k) number is K063674.

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

EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE received FDA 510(k) clearance on 2007-03-30, under 510(k) number K063674.

Who is the listed applicant for EZMANAGER 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 EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE?

The FDA product code for EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE is LZG.

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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 SYSTEMK080587EZ MANAGER 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: LZG)

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.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.

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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