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

    THYMATRON

    K Number: K843923 · Decision Dec 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    59

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    Basic Information

    Device Name
    THYMATRON
    K Number
    K843923
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5940
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Somatics, Inc.
    Date Received
    October 5, 1984
    Decision Date
    December 3, 1984
    Product Code
    QGH
    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
    QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

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    Other Clearances by Somatics, Inc.

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    K882809 THYMAPAD
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