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

    Barrier EasyWarm Active Self-Warming Blanket

    K Number: K232508 · Decision Sep 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    27
    Review Days
    28

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    Basic Information

    Device Name
    Barrier EasyWarm Active Self-Warming Blanket
    K Number
    K232508
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Molnlycke Health Care Us, LLC
    Date Received
    August 18, 2023
    Decision Date
    September 15, 2023
    Product Code
    DWJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWJ System, Thermal Regulating

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