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FDA 510(k)

INJECTOR, INSULIN

K-Number: K905062 · 1991-03-15

ApplicantSound 2000 Medical Systems, Inc.
Decision Date1991-03-15
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INJECTOR, INSULIN is the device name listed in this FDA 510(k) record. The listed applicant is Sound 2000 Medical Systems, Inc.. It received FDA 510(k) clearance on 1991-03-15 under 510(k) number K905062. The device is classified under product code KZE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INJECTOR, INSULIN?

INJECTOR, INSULIN is a medical device that received FDA 510(k) clearance on 1991-03-15. The listed applicant is Sound 2000 Medical Systems, Inc.. The 510(k) number is K905062.

When did INJECTOR, INSULIN receive FDA 510(k) clearance?

INJECTOR, INSULIN received FDA 510(k) clearance on 1991-03-15, under 510(k) number K905062.

Who is the listed applicant for INJECTOR, INSULIN?

The FDA 510(k) record lists Sound 2000 Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INJECTOR, INSULIN?

The FDA product code for INJECTOR, INSULIN is KZE.

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Related Devices (Code: KZE)

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.

K121270BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEMBioject Medical Technologies, Inc.K111517PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIPharmajet, Inc.K110456PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.K090959LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RAD'Antonio Consultants International, Inc. (Dci)K090003ZETAJETBioject, Inc.K081532PHARMAJET NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.

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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