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- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- HEQMonitor, Pressure, Arterial, Fetal, Ultrasonic2Product Code
- HEIMonitor, Heart-Valve Movement, Fetal, Ultrasonic2Product Code
- HEJMonitor, Hemic Sound, Ultrasonic2Product Code
- HEKMonitor, Heart Sound, Fetal, Ultrasonic2Product Code
- HELMonitor, Heart Rate, Fetal, Ultrasonic2Product Code
- HEMImager, Ultrasonic Obstetric-Gynecologic2Product Code
- HENCaliper, Fetal Head, Ultrasonic2Product Code
- HEOAnalyzer, Data, Obstetric3Product Code
- HEPMonitor, Blood-Flow, Ultrasonic2Product Code
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)2Product Code
- HFNTransducer, Pressure, Intrauterine2Product Code
- HFORecorder, Pressure, Intrauterine2Product Code
- HFPMonitor, Phonocardiographic, Fetal2Product Code
- HGLTransducer, Ultrasonic, Obstetric2Product Code
- HGMSystem, Monitoring, Perinatal2Product Code
- HGNStethoscope, Fetal1Product Code
- HGOMonitor, Electroencephalographic, Fetal (And Accessories)3Product Code
- HGPElectrode, Circular (Spiral), Scalp And Applicator2Product Code
- K243291Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)2Cleared 510(K)
- K030691FETAL SPIRAL ELECTRODE, MODEL FSE070002Cleared 510(K)
- K003458SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-70002Cleared 510(K)
- K943732LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE2Cleared 510(K)
- K910815CR SPIRAL ELECTRODE2Cleared 510(K)
- K911657FETAL SCALP SPIRAL ELECTRODE2Cleared 510(K)
- K905830COMBO FETAL SCALP ELECTRODE/LEGPLATE2Cleared 510(K)
- K905130FETAL MONITORING SPIRAL ELECTRODE2Cleared 510(K)
- K904745MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE2Cleared 510(K)
- K901152REDYPLATE DISPOSABLE LEG PLATE2Cleared 510(K)
Show All 17 Submissions
- HGSCatheter, Intrauterine And Introducer2Product Code
- HHJLocator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic2Product Code
- HHXHolograph, Fetal, Acoustical2Product Code
- HIQElectrode, Clip, Fetal Scalp (And Applicator)3Product Code
- KNGMonitor, Ultrasonic, Fetal2Product Code
- KXNMonitor, Cardiac, Fetal2Product Code
- KXOMonitor, Pressure, Intrauterine2Product Code
- LQKHome Uterine Activity Monitor2Product Code
- MOHMonitor, Heart Rate, Fetal, Non-Stress Test (Home Use)2Product Code
- NHMSheet, Recording, Breast Examination2Product Code
- NKASystem, Documentation, Breast Lesion2Product Code
- OSPUterine Electromyographic Monitor2Product Code
- NPBSystem, Monitoring, For Progress Of Labor2Product Code
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
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- UnknownReview Panel
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K243291
- 510(k) Type
- Traditional
- Applicant
- Neoventa Medical AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/17/2025
- Days to Decision
- 91 days
- Submission Type
- Summary