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

    DTL MICROTOUCH EYE ELECTRODE

    K Number: K882464 · Decision Nov 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    1
    Review Days
    153

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    Basic Information

    Device Name
    DTL MICROTOUCH EYE ELECTRODE
    K Number
    K882464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Lectromedics, Inc.
    Date Received
    June 15, 1988
    Decision Date
    November 15, 1988
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

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