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FDA 510(k)

SHL DISPOSABLE AUTOINJECTOR

K-Number: K050434 · 2005-06-24

ApplicantShl Medical, USA
Decision Date2005-06-24
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHL DISPOSABLE AUTOINJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Shl Medical, USA. It received FDA 510(k) clearance on 2005-06-24 under 510(k) number K050434. 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 SHL DISPOSABLE AUTOINJECTOR?

SHL DISPOSABLE AUTOINJECTOR is a medical device that received FDA 510(k) clearance on 2005-06-24. The listed applicant is Shl Medical, USA. The 510(k) number is K050434.

When did SHL DISPOSABLE AUTOINJECTOR receive FDA 510(k) clearance?

SHL DISPOSABLE AUTOINJECTOR received FDA 510(k) clearance on 2005-06-24, under 510(k) number K050434.

Who is the listed applicant for SHL DISPOSABLE AUTOINJECTOR?

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

What is the FDA product code for SHL DISPOSABLE AUTOINJECTOR?

The FDA product code for SHL DISPOSABLE AUTOINJECTOR 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 Shl Medical, USA 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.

K060141DAI-R

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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