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FDA 510(k)

ANIMUS EZSERTER INFUSION SET INSERTER

K-Number: K021700 · 2002-06-04

ApplicantAnimas Corp.
Decision Date2002-06-04
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ANIMUS EZSERTER INFUSION SET INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Animas Corp.. It received FDA 510(k) clearance on 2002-06-04 under 510(k) number K021700. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANIMUS EZSERTER INFUSION SET INSERTER?

ANIMUS EZSERTER INFUSION SET INSERTER is a medical device that received FDA 510(k) clearance on 2002-06-04. The listed applicant is Animas Corp.. The 510(k) number is K021700.

When did ANIMUS EZSERTER INFUSION SET INSERTER receive FDA 510(k) clearance?

ANIMUS EZSERTER INFUSION SET INSERTER received FDA 510(k) clearance on 2002-06-04, under 510(k) number K021700.

Who is the listed applicant for ANIMUS EZSERTER INFUSION SET INSERTER?

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 ANIMUS EZSERTER INFUSION SET INSERTER?

The FDA product code for ANIMUS EZSERTER INFUSION SET INSERTER is KZH.

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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 SOFTWAREK063674EZMANAGER MAX DIABETES MANAGEMENT SOFTWAREK042873ANIMAS MODEL IR1250 INSULIN INFUSION PUMPK032257MODEL IR 1200 INSULIN PUMPK022394EZMANAGER PLUS

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Related Devices (Code: KZH)

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.

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic MinimedK124026LOBSTER AUTO-INJECTORScandinavian Health LimitedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

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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