K243291
- 510(k) number
- K243291
- Device name
- Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
- Applicant
- Neoventa Medical AB SE
- Product code
- HGP — Electrode, Circular (Spiral), Scalp And Applicator
- Decision date
- 2025-01-17
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243291.pdf
Official FDA record: K243291
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.