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FDA 510(k)

INJET-100, FLUID INJECTOR

K-Number: K861582 · 1987-02-03

ApplicantInjet Medical Products, Inc.
Decision Date1987-02-03
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INJET-100, FLUID INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Injet Medical Products, Inc.. It received FDA 510(k) clearance on 1987-02-03 under 510(k) number K861582. 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 INJET-100, FLUID INJECTOR?

INJET-100, FLUID INJECTOR is a medical device that received FDA 510(k) clearance on 1987-02-03. The listed applicant is Injet Medical Products, Inc.. The 510(k) number is K861582.

When did INJET-100, FLUID INJECTOR receive FDA 510(k) clearance?

INJET-100, FLUID INJECTOR received FDA 510(k) clearance on 1987-02-03, under 510(k) number K861582.

Who is the listed applicant for INJET-100, FLUID INJECTOR?

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

What is the FDA product code for INJET-100, FLUID INJECTOR?

The FDA product code for INJET-100, FLUID INJECTOR 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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