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

    ATI FOREHEAD THERMOMETER

    K Number: K832651 · Decision Oct 4, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    20
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    ATI FOREHEAD THERMOMETER
    K Number
    K832651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Thermal Instruments, Inc.
    Date Received
    August 8, 1983
    Decision Date
    October 4, 1983
    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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