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

    DEKA Loop

    K Number: K234055 · Decision Mar 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    19
    Applicant Total
    13
    Review Days
    82

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    Basic Information

    Device Name
    DEKA Loop
    K Number
    K234055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1356
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deka Research and Development
    Date Received
    December 22, 2023
    Decision Date
    March 13, 2024
    Product Code
    QJI
    Advisory Committee
    Clinical Chemistry
    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
    QJI Interoperable Automated Glycemic Controller

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