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

    MeRT System

    K Number: K260402 · Decision Jun 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    117

    Basic Information

    Device Name
    MeRT System
    K Number
    K260402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5802
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wave Neuroscience
    Date Received
    February 6, 2026
    Decision Date
    June 3, 2026
    Product Code
    QCI
    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
    QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

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