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

    Extended Reservoir

    K Number: K210714 · Decision Apr 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    83
    Applicant Total
    8
    Review Days
    392

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    Basic Information

    Device Name
    Extended Reservoir
    K Number
    K210714
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Minimed, Inc.
    Date Received
    March 10, 2021
    Decision Date
    April 6, 2022
    Product Code
    LZG
    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
    LZG Pump, Infusion, Insulin

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