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510(k) K243291

Device
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
Applicant
Neoventa Medical AB
510(k) number
K243291
Product code
HGP
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-17
Date received
2024-10-18
Regulation
884.2675
Classification name
Electrode, Circular (Spiral), Scalp And Applicator
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Johan Sundberg
Address
Norra Ågatan 32 Mölndal SE SE-431 35 SE-431 35

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HGP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K030691FETAL SPIRAL ELECTRODE, MODEL FSE07000Clinical Innovations, Inc.2003-09-17
K003458SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000Clinical Innovations, Inc.2001-05-03
K943732LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCEGraphic Controls Corp.1994-10-20
K910815CR SPIRAL ELECTRODENeward Enterprises, Inc.1991-12-10
K911657FETAL SCALP SPIRAL ELECTRODEAdvanced Medical Systems, Inc.1991-07-11
K905830COMBO FETAL SCALP ELECTRODE/LEGPLATEUtah Medical Products, Inc.1991-03-29
K904745MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODEGraphic Controls Corp.1991-01-29
K905130FETAL MONITORING SPIRAL ELECTRODEGraphic Controls Corp.1991-01-29
K901152REDYPLATE DISPOSABLE LEG PLATEMedical Accessories, Inc.1990-04-04
K872057FETAL SCALP ELECTRODEMedical Accessories, Inc.1987-11-16
K871079FETALFLEX FETAL ELECTRODEEpcom Medical Systems, Inc.1987-07-13
K844608SURGICRAFT COPELAND DISPOSABLEA.W. Showell (Surgicraft) , Ltd.1985-05-01
K822584MULTI-PRONG FETAL SCALP ELECTRODEKontron Instruments, Inc.1983-02-24
K801984FE-3000 FETAL ELECTRODE, SPIRAL SYSTEMLife Support, Inc.1980-09-09
K792669COROMETRICS-PUSH BUTTON SPIRAL ELECTRODEGe Medical Systems Information Technologies1980-02-11