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510(k) Data Aggregation

    K Number
    K020780
    Device Name
    TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
    Manufacturer
    MEDEX, INC.
    Date Cleared
    2002-05-20

    (70 days)

    Product Code
    GWM
    Regulation Number
    882.1620
    Type
    Abbreviated
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    K051599
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TranStar Intracranial Pressure Transducer is intended for external monitoring of Intracranial pressures (ICP). Intracranial pressure waveforms are conducted from the patient to the transducer through a column of fluid. The fluid pressure waveforms are converted into electrical signals that can then be displayed using separate monitoring equipment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the TranStar Intracranial Pressure Transducer, which states that the device is substantially equivalent to legally marketed predicate devices.

    The letter mentions the indications for use but does not detail any performance metrics, study results, sample sizes, ground truth establishment, or expert qualifications that would be required to fulfill your request. It's a regulatory approval document, not a scientific study report.

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