BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇬🇧 United Kingdom

    Tristel Duo ULT

    K Number: DEN220041 · Decision Jun 2, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    338

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    Basic Information

    Device Name
    Tristel Duo ULT
    K Number
    DEN220041
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    880.6886
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Tristel Solutions Limited
    Date Received
    June 29, 2022
    Decision Date
    June 2, 2023
    Product Code
    QWS
    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
    QWS Foam Or Gel Chemical Sterilant/High Level Disinfectant

    Similar 510(k) Clearances

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