BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Inessa System

    K Number: K230545 · Decision Dec 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    295

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    Basic Information

    Device Name
    Inessa System
    K Number
    K230545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5730
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Triple Jump Israel , Ltd.
    Date Received
    February 28, 2023
    Decision Date
    December 20, 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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