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

    SUDOSCAN

    K Number: K141872 · Decision Nov 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    SUDOSCAN
    K Number
    K141872
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1540
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Impeto Medical, Inc.
    Date Received
    July 11, 2014
    Decision Date
    November 21, 2014
    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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