BEUDAMED
    FDA 510(k) FDA class 3 Unknown 🇺🇸 United States

    GRAPHIC STRESS TELETHERMOMETRY

    K Number: K800491 · Decision Mar 4, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    —

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    Basic Information

    Device Name
    GRAPHIC STRESS TELETHERMOMETRY
    K Number
    K800491
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    884.2980
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Applicant
    Gst Laboratories of Ca, Inc.
    Date Received
    March 4, 1980
    Decision Date
    March 4, 1980
    Product Code
    IYM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYM System, Telethermographic, Infrared

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    Other Clearances by Gst Laboratories of Ca, Inc.

    K Number Device Name
    K842878 GST SYSTEM THERMOGRAPHIC APPLICATION