BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇫🇷 France

    Chronos®

    K Number: DEN230067 · Decision Aug 28, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    335

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    Basic Information

    Device Name
    Chronos®
    K Number
    DEN230067
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    880.6511
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Germitec
    Date Received
    September 28, 2023
    Decision Date
    August 28, 2024
    Product Code
    SCS
    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
    SCS Ultraviolet Radiation Disinfection Chamber Device

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