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    K Number
    K070259
    Device Name
    EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
    Manufacturer
    BEDFONT SCIENTIFIC LTD.
    Date Cleared
    2008-02-21

    (391 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K892841,K000962
    Why did this record match?
    Device Name :

    EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR

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

    The EC50 ToxCO+ Breath Carbon Monoxide Monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.

    Device Description

    The EC50 ToxCO+ Breath Carbon Monoxide Monitor is a handheld device, which provides a non-invasive means of determining Carbon Monoxide (CO) poisoning and Carboxyhaemoglobin (COHb) when blood testing is not available. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is also ideal for use during triage to ensure suspected cases of CO poisoning are not missed. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is a microprocessor-controlled device powered by 2 AA batteries with an Alphanumerice LCD display housed in a sturdy ABS case with a synthetic rubber boot. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is designed to have an operating temperature between 0-30° C, operating humidity 10-95% non-condensing and has storage temperature requirements of 0-30° C. The sensor sensitivity is 1 pmm, has a warm up time of

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

    Device: EC50 ToxCO+ Breath Carbon Monoxide Monitor

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided documentation does not explicitly define a formal "acceptance criteria" table with specific thresholds that the device must meet to be deemed acceptable. Instead, it relies on comparison to predicate devices and reported specifications.

    Acceptance Criteria (Implied)Reported Device Performance (EC50 ToxCO+)
    Accuracy: Comparable to predicate devices±5% of reading
    Concentration Range: Comparable to predicate devices0-50% COHb/0-500ppm CO
    Sensor Sensitivity: Comparable to predicate devices1 ppm
    Warm-up Time: Comparable to predicate devices
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