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FDA 510(k)

BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM

K-Number: K121270 · 2012-07-19

ApplicantBioject Medical Technologies, Inc.
Decision Date2012-07-19
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bioject Medical Technologies, Inc.. It received FDA 510(k) clearance on 2012-07-19 under 510(k) number K121270. 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 BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM?

BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-19. The listed applicant is Bioject Medical Technologies, Inc.. The 510(k) number is K121270.

When did BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM receive FDA 510(k) clearance?

BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM received FDA 510(k) clearance on 2012-07-19, under 510(k) number K121270.

Who is the listed applicant for BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM?

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

What is the FDA product code for BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM?

The FDA product code for BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM is KZE.

Related Clinical Trials

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Other records listing Bioject Medical Technologies, 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.

K043304Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01K041564Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01

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.

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.K082138AIRGENT, MODEL AG7000010Perfaction, 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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