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

    iLet® ACE Pump

    K Number: K223846 · Decision May 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    150

    Basic Information

    Device Name
    iLet® ACE Pump
    K Number
    K223846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5730
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beta Bionics, Inc
    Date Received
    December 20, 2022
    Decision Date
    May 19, 2023
    Product Code
    QFG
    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
    QFG Alternate Controller Enabled Insulin Infusion Pump

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