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

    IASIS i2 Relaxation Neurofeedback System

    K Number: K252923 · Decision Mar 13, 2026
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    179

    Basic Information

    Device Name
    IASIS i2 Relaxation Neurofeedback System
    K Number
    K252923
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iasis Technologies
    Date Received
    September 15, 2025
    Decision Date
    March 13, 2026
    Advisory Committee
    Unknown
    Review Advisory Committee
    NE
    Third Party
    N