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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Circular (Spiral), Scalp And Applicator
510(k) Number K243291
Device Name Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
Applicant
Neoventa Medical AB
Norra Ågatan 32
Mölndal,  SE SE-431 35
Applicant Contact Johan Sundberg
Correspondent
Neoventa Medical AB
Norra Ågatan 32
Mölndal,  SE SE-431 35
Correspondent Contact Johan Sundberg
Regulation Number884.2675
Classification Product Code
HGP  
Date Received10/18/2024
Decision Date 01/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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