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

    Celsi Warmer

    K Number: K242964 · Decision Jun 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    2
    Review Days
    267

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    Basic Information

    Device Name
    Celsi Warmer
    K Number
    K242964
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hadleigh Health Technologies
    Date Received
    September 26, 2024
    Decision Date
    June 20, 2025
    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 Hadleigh Health Technologies

    K Number Device Name
    K230298 Celsi Monitor