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

    EPI-SCAN, MODEL P 100

    K Number: K032935 · Decision Nov 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    59

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    Basic Information

    Device Name
    EPI-SCAN, MODEL P 100
    K Number
    K032935
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1540
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edx Epi-Scan, Inc.
    Date Received
    September 22, 2003
    Decision Date
    November 20, 2003
    Product Code
    GZO
    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
    GZO Device, Galvanic Skin Response Measurement

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