BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    TECOTHERM NEO (T NEO)

    K Number: K140078 · Decision Nov 14, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    1
    Review Days
    305

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    Basic Information

    Device Name
    TECOTHERM NEO (T NEO)
    K Number
    K140078
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inspiration Healthcare, Ltd.
    Date Received
    January 13, 2014
    Decision Date
    November 14, 2014
    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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