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    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    VITAJET(INSULIN JET INJECTION DEVICE)

    K Number: K893215 · Decision May 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    375

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    Basic Information

    Device Name
    VITAJET(INSULIN JET INJECTION DEVICE)
    K Number
    K893215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5430
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Vitajet Industriae Comercioltda.
    Date Received
    April 27, 1989
    Decision Date
    May 7, 1990
    Product Code
    KZE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KZE Injector, Fluid, Non-Electrically Powered

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    Other Clearances by Vitajet Industriae Comercioltda.

    K Number Device Name
    K843784 VITAJET JET INSULIN INJECTION DEVICE