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

    SoClean 3+

    K Number: K243815 · Decision Oct 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    303

    Basic Information

    Device Name
    SoClean 3+
    K Number
    K243815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6993
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Soclean, Inc.
    Date Received
    December 11, 2024
    Decision Date
    October 10, 2025
    Product Code
    QXQ
    Advisory Committee
    General Hospital
    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
    QXQ Respiratory Accessory Microbial Reduction Device.

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