BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    trophon2

    K Number: K250434 · Decision Aug 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    172

    Basic Information

    Device Name
    trophon2
    K Number
    K250434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanosonics
    Date Received
    February 14, 2025
    Decision Date
    August 5, 2025
    Product Code
    OUJ
    Advisory Committee
    Radiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

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