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FDA 510(k)

J-TIP INJECTOR SYSTEM

K-Number: K884293 · 1989-01-09

ApplicantCalifornia Medical Innovations, Inc.
Decision Date1989-01-09
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

J-TIP INJECTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is California Medical Innovations, Inc.. It received FDA 510(k) clearance on 1989-01-09 under 510(k) number K884293. 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 J-TIP INJECTOR SYSTEM?

J-TIP INJECTOR SYSTEM is a medical device that received FDA 510(k) clearance on 1989-01-09. The listed applicant is California Medical Innovations, Inc.. The 510(k) number is K884293.

When did J-TIP INJECTOR SYSTEM receive FDA 510(k) clearance?

J-TIP INJECTOR SYSTEM received FDA 510(k) clearance on 1989-01-09, under 510(k) number K884293.

Who is the listed applicant for J-TIP INJECTOR SYSTEM?

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

What is the FDA product code for J-TIP INJECTOR SYSTEM?

The FDA product code for J-TIP INJECTOR SYSTEM 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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