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FDA 510(k)

PERSONAL INJECTOR

K-Number: K033696 · 2005-02-16

ApplicantUnion Medico Aps
Decision Date2005-02-16
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PERSONAL INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Union Medico Aps. It received FDA 510(k) clearance on 2005-02-16 under 510(k) number K033696. 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 PERSONAL INJECTOR?

PERSONAL INJECTOR is a medical device that received FDA 510(k) clearance on 2005-02-16. The listed applicant is Union Medico Aps. The 510(k) number is K033696.

When did PERSONAL INJECTOR receive FDA 510(k) clearance?

PERSONAL INJECTOR received FDA 510(k) clearance on 2005-02-16, under 510(k) number K033696.

Who is the listed applicant for PERSONAL INJECTOR?

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

What is the FDA product code for PERSONAL INJECTOR?

The FDA product code for PERSONAL INJECTOR is KZH.

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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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