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510(k) Data Aggregation

    K Number
    K082315
    Device Name
    EC50 MICRO+ SMOKERLYZER
    Manufacturer
    BEDFONT SCIENTIFIC LTD.
    Date Cleared
    2010-02-01

    (537 days)

    Product Code
    CCJ, DLJ, LAS
    Regulation Number
    868.1430
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEDFONT SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEDFONT SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 <10 seconds-90% FSD, an accuracy of ±5% of reading, a concentration range of 0-50% COHb/0-500ppm CO and an H2 Cross Interference of <40% @ 20° C. The sensor operating life is 2-3 years with a company warranty of 6 months and requires calibrations at 6-month intervals. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is an easy to use handheld device that has three clearly marked buttons: ON button, CAL calibration button, RECALL button.
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    K Number
    K000962
    Device Name
    PICO SMOKERLYZER, MODEL EC-50
    Manufacturer
    BEDFONT SCIENTIFIC LTD.
    Date Cleared
    2000-04-20

    (27 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEDFONT SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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