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

    ROBINJECT

    K Number: K864984 · Decision Jun 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    9
    Review Days
    189

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    Basic Information

    Device Name
    ROBINJECT
    K Number
    K864984
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5430
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    International Medical Products, Inc.
    Date Received
    December 22, 1986
    Decision Date
    June 29, 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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