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

    DERATA MEDI-JECTOR III

    K Number: K844111 · Decision Nov 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    36

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    Basic Information

    Device Name
    DERATA MEDI-JECTOR III
    K Number
    K844111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5430
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Derata Corp.
    Date Received
    October 23, 1984
    Decision Date
    November 28, 1984
    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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    K864561 DERATA MEDI-JECTOR IV
    K844244 DERATA MEDI-JECTOR PRO
    K834044 MEDI-JECTOR II
    K772129 MEDI-JECTOR