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

    iLet® Dosing Decision Software

    K Number: K232224 · Decision Sep 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    57

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    Basic Information

    Device Name
    iLet® Dosing Decision Software
    K Number
    K232224
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1356
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beta Bionics, Inc.
    Date Received
    July 27, 2023
    Decision Date
    September 22, 2023
    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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