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    K Number
    K981939
    Device Name
    AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1998-08-20

    (79 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K970209
    Why did this record match?
    Device Name :

    AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR

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

    The BCI 3404 Monitor is a portable ECG and oximetry monitor with optional impedance respiration. It continuously and non-invasively monitors and displays functional oxygen saturation of arterial hemoglobin(SpO2), pulse rate, respiration rate, plethysmogram and ECG waveforms. Alarms are available for ECG and oximetry. There are no respiration rate alarms. The 3404 may be used in the hospital or clinical environment, and during emergency land transport.

    The device will provide fast, reliable measurements on patients ranging from pediatric to adult when using the appropriate BCI accessories.

    The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. The monitor is not intended for neonatal use.

    Device Description

    The BCI 3404 Oximeter / ECG Monitor is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a table top design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys ( on/off, waveform / trend, alarm silence, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the BCI 3404 Oximeter / ECG Monitor, based on the provided text:

    1. Acceptance Criteria and Reported Device Performance

    ParameterAcceptance CriteriaReported Device Performance (Mean Error ± SD)
    Bench Tests
    ECG Rates (beats per minute)±2 bpm or ±2% (greater of)0 bpm ± 0 bpm
    Oximetry % SpO2±2% SpO2 (min)0.25% ± 0.45%
    Oximetry Pulse Rate (bpm)±2 bpm or ±2% (greater of)1.18 bpm ± 0.90 bpm
    Respiration (breaths per minute)±1 bpm or ±5% (greater of)0 bpm ± 0 bpm
    Clinical Tests (Oximetry)
    SpO2 (70% - 100%)Standard Deviation ≤ 2.0%1.8% (Standard Deviation)
    SpO2 (50% -
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