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FDA 510(k)

PEN-INJECT 2.25

K-Number: K954729 · 1996-01-29

ApplicantScandinavian Health , Ltd.
Decision Date1996-01-29
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PEN-INJECT 2.25 is the device name listed in this FDA 510(k) record. The listed applicant is Scandinavian Health , Ltd.. It received FDA 510(k) clearance on 1996-01-29 under 510(k) number K954729. 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 PEN-INJECT 2.25?

PEN-INJECT 2.25 is a medical device that received FDA 510(k) clearance on 1996-01-29. The listed applicant is Scandinavian Health , Ltd.. The 510(k) number is K954729.

When did PEN-INJECT 2.25 receive FDA 510(k) clearance?

PEN-INJECT 2.25 received FDA 510(k) clearance on 1996-01-29, under 510(k) number K954729.

Who is the listed applicant for PEN-INJECT 2.25?

The FDA 510(k) record lists Scandinavian Health , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEN-INJECT 2.25?

The FDA product code for PEN-INJECT 2.25 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

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

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