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510(k) Data Aggregation

    K Number
    K033988
    Device Name
    GOLDWAY UT4000A VITAL SIGNS MONITOR
    Manufacturer
    GOLDWAY (US), INC.
    Date Cleared
    2004-02-25

    (64 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K021154
    Why did this record match?
    Reference Devices :

    K021154

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Goldway UT4000A Vital Signs Monitor is intended to monitor basic physiological parameters of patients from adults to neonates within any professional medical environment. The user, responsible to interpret the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data analysis will be made available to the user from the monitor.

    Physiological data includes: electrocardiograph, non-invasive blood pressure, and pulse oximetry.

    Goldway UT4000A is not intended for use as an apnea monitor. Goldway UT4000A is not intended for use during MRI or CT scans.

    The UT4000A is not designed for home use. The device is restricted to be used on one patient at a time.

    Device Description

    The Goldway UT4000A monitor interprets and displays physiological data of the patient including waveforms and numerical data in real time. Goldway UT4000A can be custom configured to monitor electrocardiograph (ECG), non-invasive blood pressure (NIBP), or pulse oximetry (SpO2). For each patient vital parameter, Goldway UT4000A will be capable of providing limit alarms and alerts, storing data trends for retrospective review and sending serial port signal to printer for report printing.

    AI/ML Overview

    This document, a 510(k) Summary for the Goldway UT4000A Vital Signs Monitor, states that no clinical tests were performed to establish its safety and effectiveness. Therefore, it does not contain information on acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as requested.

    The device's substantial equivalence to a predicate device (Goldway Model UT4000F Patient Monitor) is based on non-clinical tests (meeting various standards listed in section 7) and a comparison of their intended use and technological characteristics. The document explicitly states:

    "8. Discussion on Clinical Tests Performed: Not Applicable."

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study is presented in the provided text.

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