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FDA 510(k)

THE INJECTOR

K-Number: K862325 · 1987-02-27

ApplicantAmerican Medical Innovations, Inc.
Decision Date1987-02-27
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Innovations, Inc.. It received FDA 510(k) clearance on 1987-02-27 under 510(k) number K862325. 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 THE INJECTOR?

THE INJECTOR is a medical device that received FDA 510(k) clearance on 1987-02-27. The listed applicant is American Medical Innovations, Inc.. The 510(k) number is K862325.

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

THE INJECTOR received FDA 510(k) clearance on 1987-02-27, under 510(k) number K862325.

Who is the listed applicant for THE INJECTOR?

The FDA 510(k) record lists American Medical Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE INJECTOR?

The FDA product code for THE 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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