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

    ORTHO-THERM INFRARED SENSOR

    K Number: K812701 · Decision Oct 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    11
    Review Days
    20

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    Basic Information

    Device Name
    ORTHO-THERM INFRARED SENSOR
    K Number
    K812701
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    884.2980
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Orthion Corp.
    Date Received
    September 23, 1981
    Decision Date
    October 13, 1981
    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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