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

    ELEX ELECTRONIC DIGITAL THERMOMETER

    K Number: K843609 · Decision Jan 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    518
    Registration Numbers
    518
    Same Product Code
    795
    Applicant Total
    1
    Review Days
    134

    Basic Information

    Device Name
    ELEX ELECTRONIC DIGITAL THERMOMETER
    K Number
    K843609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    EWING INTL. LTD.
    Date Received
    September 13, 1984
    Decision Date
    January 25, 1985
    Product Code
    FLL
    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
    FLL Continuous Measurement Thermometer

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