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

    Emily's Care Nourish Test System (Model 1)

    K Number: K234088 · Decision May 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    Emily's Care Nourish Test System (Model 1)
    K Number
    K234088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1493
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lactation Lab, Inc.
    Date Received
    December 22, 2023
    Decision Date
    May 3, 2024
    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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