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    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Miris Human Milk Analyzer (HMA)

    K Number: K223085 · Decision Sep 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    364

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    Basic Information

    Device Name
    Miris Human Milk Analyzer (HMA)
    K Number
    K223085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1493
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miris AB
    Date Received
    September 30, 2022
    Decision Date
    September 29, 2023
    Product Code
    QEI
    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
    QEI Breast Milk Macronutrients Test System

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    Other Clearances by Miris AB

    K Number Device Name
    DEN180007 Miris Human Milk Analyzer