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

    BT-001

    K Number: DEN220058 · Decision Jul 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    289

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    Basic Information

    Device Name
    BT-001
    K Number
    DEN220058
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    880.5735
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Better Therapeutics
    Date Received
    September 21, 2022
    Decision Date
    July 7, 2023
    Product Code
    QXC
    Advisory Committee
    General Hospital
    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
    QXC Diabetes Digital Therapeutic Device