BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)

    K Number: K060189 · Decision May 30, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    52
    Applicant Total
    3
    Review Days
    126

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    Basic Information

    Device Name
    PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
    K Number
    K060189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1350
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ives Eeg Solutions, Inc.
    Date Received
    January 24, 2006
    Decision Date
    May 30, 2006
    Product Code
    GXZ
    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
    GXZ Electrode, Needle

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    Other Clearances by Ives Eeg Solutions, Inc.

    K Number Device Name
    K071118 GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE
    K062880 SUBDERMAL WIRE ELECTRODE, MODEL SWE