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FDA 510(k)

HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500

K-Number: K041280 · 2004-06-24

ApplicantFelton International, Inc.
Decision Date2004-06-24
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 is the device name listed in this FDA 510(k) record. The listed applicant is Felton International, Inc.. It received FDA 510(k) clearance on 2004-06-24 under 510(k) number K041280. 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 HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500?

HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 is a medical device that received FDA 510(k) clearance on 2004-06-24. The listed applicant is Felton International, Inc.. The 510(k) number is K041280.

When did HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 receive FDA 510(k) clearance?

HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 received FDA 510(k) clearance on 2004-06-24, under 510(k) number K041280.

Who is the listed applicant for HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500?

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

What is the FDA product code for HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500?

The FDA product code for HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 is KZE.

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Other records listing Felton International, 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.

K013256BI-3M NEEDLE-FREE INJECTOR 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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