BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DERATA MEDI-JECTOR IV

    K Number: K864561 · Decision Feb 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    92

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    Basic Information

    Device Name
    DERATA MEDI-JECTOR IV
    K Number
    K864561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5430
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Derata Corp.
    Date Received
    November 19, 1986
    Decision Date
    February 19, 1987
    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 Derata Corp.

    K Number Device Name
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    K844244 DERATA MEDI-JECTOR PRO
    K844111 DERATA MEDI-JECTOR III
    K834044 MEDI-JECTOR II
    K772129 MEDI-JECTOR