Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VITAJET JET INSULIN INJECTION DEVICE

K-Number: K843784 · 1984-11-02

ApplicantVitajet Industriae Comercioltda.
Decision Date1984-11-02
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VITAJET JET INSULIN INJECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Vitajet Industriae Comercioltda.. It received FDA 510(k) clearance on 1984-11-02 under 510(k) number K843784. 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 VITAJET JET INSULIN INJECTION DEVICE?

VITAJET JET INSULIN INJECTION DEVICE is a medical device that received FDA 510(k) clearance on 1984-11-02. The listed applicant is Vitajet Industriae Comercioltda.. The 510(k) number is K843784.

When did VITAJET JET INSULIN INJECTION DEVICE receive FDA 510(k) clearance?

VITAJET JET INSULIN INJECTION DEVICE received FDA 510(k) clearance on 1984-11-02, under 510(k) number K843784.

Who is the listed applicant for VITAJET JET INSULIN INJECTION DEVICE?

The FDA 510(k) record lists Vitajet Industriae Comercioltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITAJET JET INSULIN INJECTION DEVICE?

The FDA product code for VITAJET JET INSULIN INJECTION DEVICE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vitajet Industriae Comercioltda. 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.

K893215VITAJET(INSULIN JET INJECTION DEVICE)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑