BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Accu-Chek Solo micropump system with interoperable technology

    K Number: K213134 · Decision Aug 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    682

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    Basic Information

    Device Name
    Accu-Chek Solo micropump system with interoperable technology
    K Number
    K213134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5730
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diabetes Care GmbH
    Date Received
    September 27, 2021
    Decision Date
    August 10, 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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    Other Clearances by Roche Diabetes Care GmbH

    K Number Device Name
    K213131 Accu-Chek Guide Solo diabetes manager blood glucose monitoring system