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FDA 510(k)

LOBSTER AUTO-INJECTOR

K-Number: K124026 · 2013-09-13

ApplicantScandinavian Health Limited
Decision Date2013-09-13
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LOBSTER AUTO-INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Scandinavian Health Limited. It received FDA 510(k) clearance on 2013-09-13 under 510(k) number K124026. 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 LOBSTER AUTO-INJECTOR?

LOBSTER AUTO-INJECTOR is a medical device that received FDA 510(k) clearance on 2013-09-13. The listed applicant is Scandinavian Health Limited. The 510(k) number is K124026.

When did LOBSTER AUTO-INJECTOR receive FDA 510(k) clearance?

LOBSTER AUTO-INJECTOR received FDA 510(k) clearance on 2013-09-13, under 510(k) number K124026.

Who is the listed applicant for LOBSTER AUTO-INJECTOR?

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

What is the FDA product code for LOBSTER AUTO-INJECTOR?

The FDA product code for LOBSTER AUTO-INJECTOR 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 Scandinavian Health 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.

K120191PUSH-ON NEEDLE 30GX8MM

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 MinimedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.K111467FLEXI-Q DV AND DVR AUTO-INJECTORSElcam Medical Acal

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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