BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RUB E-Z

    K Number: K854396 · Decision May 8, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    189

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    Basic Information

    Device Name
    RUB E-Z
    K Number
    K854396
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1410
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    E-Z Instruments Co.
    Date Received
    October 31, 1985
    Decision Date
    May 8, 1986
    Product Code
    GYA
    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
    GYA Tester, Electrode/Lead, Electroencephalograph

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