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

    ARC ADAPTER ASSEMBLY

    K Number: K874833 · Decision Mar 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    7
    Review Days
    100

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    Basic Information

    Device Name
    ARC ADAPTER ASSEMBLY
    K Number
    K874833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Medical Equipment Development Co., Inc.
    Date Received
    November 24, 1987
    Decision Date
    March 3, 1988
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

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