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

    SKIN TEMPERATURE SENSING VINYL STRIP

    K Number: K813199 · Decision Mar 5, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    20
    Applicant Total
    5
    Review Days
    112

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    Basic Information

    Device Name
    SKIN TEMPERATURE SENSING VINYL STRIP
    K Number
    K813199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    T. G. & E. Medical
    Date Received
    November 13, 1981
    Decision Date
    March 5, 1982
    Product Code
    KPD
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPD Strip, Temperature, Forehead, Liquid Crystal

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