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

    AD-TECH'S DEPTH ELECTRODE

    K Number: K964644 · Decision May 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    57
    Applicant Total
    18
    Review Days
    190

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    Basic Information

    Device Name
    AD-TECH'S DEPTH ELECTRODE
    K Number
    K964644
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ad-Tech Medical Instrument Corp
    Date Received
    October 31, 1996
    Decision Date
    May 9, 1997
    Product Code
    GZL
    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
    GZL Electrode, Depth

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    Other Clearances by Ad-Tech Medical Instrument Corp

    K Number Device Name
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    K041604 MACRO-MICRO DEPTH ELECTRODE
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