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510(k) Data Aggregation

    K Number
    K243291
    Device Name
    Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
    Manufacturer
    Neoventa Medical AB
    Date Cleared
    2025-01-17

    (91 days)

    Product Code
    HGP
    Regulation Number
    884.2675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neoventa Medical AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Goldtrace FSE is indicated for patients requiring continuous electronic intrapartum monitoring of the fetal heart rate during labor and delivery.
    Device Description
    Goldtrace FSE is a sterile, single use device transmitting the fetal ECG signal for continuous electronic intrapartum monitoring. The device consists of gold-plated stainless steel spiral needle electrode that attaches to the fetal presenting part. The device includes a reference plate to measure the reference voltage level in the amniotic fluid. A guide tube and drive tube are used for application to the fetal presenting part. The subject device is connected to a compatible monitor (e.g., Philips Avalon FM30) via Philips DECG Reusable Legplate adaptor cable to provide a fetal ECG signal to the monitor. The subject device does not perform any conversion, analysis, quantification, or modifications to the fetal ECG.
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