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FDA 510(k)

AUTO-INJECTOR, SURE-INJECT 2000

K-Number: K981266 · 1998-07-14

ApplicantMighty Mo, Corp.
Decision Date1998-07-14
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTO-INJECTOR, SURE-INJECT 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Mighty Mo, Corp.. It received FDA 510(k) clearance on 1998-07-14 under 510(k) number K981266. 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-INJECTOR, SURE-INJECT 2000?

AUTO-INJECTOR, SURE-INJECT 2000 is a medical device that received FDA 510(k) clearance on 1998-07-14. The listed applicant is Mighty Mo, Corp.. The 510(k) number is K981266.

When did AUTO-INJECTOR, SURE-INJECT 2000 receive FDA 510(k) clearance?

AUTO-INJECTOR, SURE-INJECT 2000 received FDA 510(k) clearance on 1998-07-14, under 510(k) number K981266.

Who is the listed applicant for AUTO-INJECTOR, SURE-INJECT 2000?

The FDA 510(k) record lists Mighty Mo, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO-INJECTOR, SURE-INJECT 2000?

The FDA product code for AUTO-INJECTOR, SURE-INJECT 2000 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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