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

    MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)

    K Number: K151236 · Decision May 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    1
    Applicant Total
    8
    Review Days
    8

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    Basic Information

    Device Name
    MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
    K Number
    K151236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1350
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Minimed, Inc.
    Date Received
    May 11, 2015
    Decision Date
    May 19, 2015
    Product Code
    PJT
    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
    PJT Continuous Glucose Monitor Secondary Display

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