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510(k) Data Aggregation
K Number
K243291Device Name
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
Manufacturer
Neoventa Medical AB
Date Cleared
2025-01-17
(91 days)
Product Code
HGP
Regulation Number
884.2675Why 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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