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FDA 510(k)

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)

K-Number: K243291 · 2025-01-17

ApplicantNeoventa Medical AB
Decision Date2025-01-17
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) is a medical device manufactured by Neoventa Medical AB. It received FDA 510(k) clearance on 2025-01-17 under approval number K243291. The device is classified under product code HGP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)?

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Neoventa Medical AB. The 510(k) number is K243291.

When was Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) approved by the FDA?

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) received FDA 510(k) clearance on 2025-01-17, under approval number K243291.

What company makes Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)?

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) is manufactured by Neoventa Medical AB.

What is the FDA product code for Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)?

The FDA product code for Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) is HGP.

Related Clinical Trials

NCT01400880 Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability COMPLETED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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