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

    BiliWrap

    K Number: K243372 · Decision May 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    70
    Applicant Total
    1
    Review Days
    211

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    Basic Information

    Device Name
    BiliWrap
    K Number
    K243372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5700
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gerium Medical, Ltd.
    Date Received
    October 30, 2024
    Decision Date
    May 29, 2025
    Product Code
    LBI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LBI Unit, Neonatal Phototherapy

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