BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    POINT CHECKER COLOR STRIP THERMOMETER

    K Number: K894893 · Decision Apr 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    247

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    Basic Information

    Device Name
    POINT CHECKER COLOR STRIP THERMOMETER
    K Number
    K894893
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2900
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Kyowa Medex Co., Ltd.
    Date Received
    August 1, 1989
    Decision Date
    April 5, 1990
    Product Code
    FQZ
    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
    FQZ Thermometer, Clinical Color Change

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