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FDA 510(k)

HYPEX(TM) JET INJECTOR

K-Number: K945873 · 1995-08-18

ApplicantEquidyne Systems, Inc.
Decision Date1995-08-18
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYPEX(TM) JET INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Equidyne Systems, Inc.. It received FDA 510(k) clearance on 1995-08-18 under 510(k) number K945873. 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 HYPEX(TM) JET INJECTOR?

HYPEX(TM) JET INJECTOR is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is Equidyne Systems, Inc.. The 510(k) number is K945873.

When did HYPEX(TM) JET INJECTOR receive FDA 510(k) clearance?

HYPEX(TM) JET INJECTOR received FDA 510(k) clearance on 1995-08-18, under 510(k) number K945873.

Who is the listed applicant for HYPEX(TM) JET INJECTOR?

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

What is the FDA product code for HYPEX(TM) JET INJECTOR?

The FDA product code for HYPEX(TM) JET INJECTOR is KZE.

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 Equidyne Systems, Inc. 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.

K022502INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000K022148INJEX 30 NEEDLE FREE INJECTION SYSTEMK003741JET SYRINGE MODEL-100500K003864INJEX 50 SYSTEM

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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