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

    Level 1 Convective Warmer

    K Number: K181699 · Decision Jul 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    52
    Review Days
    29

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    Basic Information

    Device Name
    Level 1 Convective Warmer
    K Number
    K181699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Medical Asd, Inc.
    Date Received
    June 27, 2018
    Decision Date
    July 26, 2018
    Product Code
    DWJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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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