BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    T1D1

    K Number: K252104 · Decision Aug 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    48

    Basic Information

    Device Name
    T1D1
    K Number
    K252104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Comerge AG
    Date Received
    July 3, 2025
    Decision Date
    August 20, 2025
    Product Code
    NDC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NDC Calculator, Drug Dose

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