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

    JEOL MODEL #JTG-500M

    K Number: K823041 · Decision Nov 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    41

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    JEOL MODEL #JTG-500M
    K Number
    K823041
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    884.2980
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Jeol
    Date Received
    October 14, 1982
    Decision Date
    November 24, 1982
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IYM), ordered by most recent decision date.

    FMS MODEL 110

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    VISITHERM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    DCATS

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    ORTHO-THERM INFRARED SENSOR

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    THERMOCOMP

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    GRAPHIC STRESS TELETHERMOMETRY

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology
    View all