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

    MECTA Sigma

    K Number: K192834 · Decision Apr 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    207

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    Basic Information

    Device Name
    MECTA Sigma
    K Number
    K192834
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5940
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mecta Corporation
    Date Received
    October 2, 2019
    Decision Date
    April 26, 2020
    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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