BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Cocoon Convective Warming System, Model CWS7000

    K Number: K232502 · Decision Feb 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    154
    Applicant Total
    3
    Review Days
    187

    Basic Information

    Device Name
    Cocoon Convective Warming System, Model CWS7000
    K Number
    K232502
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Care Essentials Pty Ltd
    Date Received
    August 18, 2023
    Decision Date
    February 21, 2024
    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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    Other Clearances by Care Essentials Pty Ltd

    K Number Device Name
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