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510(k) Data Aggregation

    K Number
    K994008
    Device Name
    BIOSYS FETAL MONITOR, MODEL IFM-500
    Manufacturer
    BIOSYS CO. LTD.
    Date Cleared
    2000-09-29

    (310 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOSYS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IFM-500 is an Perinatal Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single or twin fetal heart rates may be measured by means of Pulsed Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.
    Device Description
    The IFM-500 is an Perinatal Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single or twin fetal heart rates may be measured by means of Pulsed Doppler Ultrasound. Uterine Contraction (UC) is measured with an external TOCO transducer.
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