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

Name: FDA 510(k) clearance K243291
Creator: U.S. Food and Drug Administration
Published: 2025-01-17

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. Device class: 2.

Clearance details

Applicant: Neoventa Medical AB
Product code: Code HGP
Device class: Class 2
Regulation: 21 CFR 884.2675
Advisory panel: Obstetrics/Gynecology
Date received: 2024-10-18
Decision date: 2025-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mölndal, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGP

view all

K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE070002003-09-17
K003458 — SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-70002001-05-03
K943732 — LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE1994-10-20
K910815 — CR SPIRAL ELECTRODE1991-12-10
K911657 — FETAL SCALP SPIRAL ELECTRODE1991-07-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.