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FDA 510(k)

AUTO-SAFETY INJECTOR-2 (ASI-2)

K-Number: K082587 · 2008-10-02

ApplicantMedical House Products Limited
Decision Date2008-10-02
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTO-SAFETY INJECTOR-2 (ASI-2) is the device name listed in this FDA 510(k) record. The listed applicant is Medical House Products Limited. It received FDA 510(k) clearance on 2008-10-02 under 510(k) number K082587. 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 AUTO-SAFETY INJECTOR-2 (ASI-2)?

AUTO-SAFETY INJECTOR-2 (ASI-2) is a medical device that received FDA 510(k) clearance on 2008-10-02. The listed applicant is Medical House Products Limited. The 510(k) number is K082587.

When did AUTO-SAFETY INJECTOR-2 (ASI-2) receive FDA 510(k) clearance?

AUTO-SAFETY INJECTOR-2 (ASI-2) received FDA 510(k) clearance on 2008-10-02, under 510(k) number K082587.

Who is the listed applicant for AUTO-SAFETY INJECTOR-2 (ASI-2)?

The FDA 510(k) record lists Medical House Products Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO-SAFETY INJECTOR-2 (ASI-2)?

The FDA product code for AUTO-SAFETY INJECTOR-2 (ASI-2) is KZH.

Related Clinical Trials

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.

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Other records listing Medical House Products Limited 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.

K060819COOL.CLICK 2

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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