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

    SKIN GALVANOMETER

    K Number: K823194 · Decision Jan 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    SKIN GALVANOMETER
    K Number
    K823194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Spelson Research Laboratories, Inc.
    Date Received
    October 26, 1982
    Decision Date
    January 21, 1983
    Product Code
    HCJ
    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
    HCJ Device, Skin Potential Measurement

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