Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)— 510(k) K243291

Substantially Equivalent

Neoventa Medical AB

FDA 510(k) clearance K243291 for Goldtrace Fetal Spiral Electrode (FSE) (CNS000004), Substantially Equivalent on 2025-01-17. Applicant: Neoventa Medical AB.

Clearance details

Applicant: Neoventa Medical AB
Product code: Code HGP
Advisory panel: Obstetrics/Gynecology
Date received: 2024-10-18
Decision date: 2025-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mölndal, SE

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