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FDA 510(k)

INJECTION AIDE UNIT FOR DIAGETICS

K-Number: K834440 · 1984-02-04

ApplicantGottinger Co.
Decision Date1984-02-04
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INJECTION AIDE UNIT FOR DIAGETICS is the device name listed in this FDA 510(k) record. The listed applicant is Gottinger Co.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K834440. 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 INJECTION AIDE UNIT FOR DIAGETICS?

INJECTION AIDE UNIT FOR DIAGETICS is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Gottinger Co.. The 510(k) number is K834440.

When did INJECTION AIDE UNIT FOR DIAGETICS receive FDA 510(k) clearance?

INJECTION AIDE UNIT FOR DIAGETICS received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834440.

Who is the listed applicant for INJECTION AIDE UNIT FOR DIAGETICS?

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

What is the FDA product code for INJECTION AIDE UNIT FOR DIAGETICS?

The FDA product code for INJECTION AIDE UNIT FOR DIAGETICS 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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