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

    TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER

    K Number: K023538 · Decision Nov 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    11

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    Basic Information

    Device Name
    TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
    K Number
    K023538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medport, Inc.
    Date Received
    October 21, 2002
    Decision Date
    November 1, 2002
    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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    Other Clearances by Medport, Inc.

    K Number Device Name
    K070577 ON THE GO SHARPS
    K023069 TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER