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510(k) Data Aggregation

    K Number
    K211918
    Device Name
    iCOquit® Smokerlyzer®
    Manufacturer
    Bedfont Scientific Ltd
    Date Cleared
    2021-12-21

    (183 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Product Code :

    CCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iCOquit® Smokelyzer® breath carbon monoxide (CO) monitor is intended for single patient use by cigarette smoking individuals, notifying the individual user of the amount of CO on their breath produced as a consequence of smoking activity. The device can be used in smoking cessation programmes.
    Device Description
    The iCOquit® Smokerlyzer® device is a hand-held breath monitor for the detection of Carbon Monoxide (CO) on the breath, using a non-invasive method of breath analysis to detect levels of Carbon Monoxide (CO). The iCOquit® Smokerlyzer® device works in conjunction with the iCOquit® App developed for smartphone or tablet, which the user pairs to the device via Bluetooth. The iCOquit® App works in conjunction with the iCOquit® Smokerlyzer® personal stop-smoking tool to provide visual motivation to help the user quit as track their quitting progress in real-time. The iCOquit® Smokerlyzer® is an over-the-counter, hand-held breath monitor. It is not for use with other inhaled products. Using an electrochemical sensor designed to react specifically to carbon monoxide producing an electrical output, the sensor measures the level of carbon monoxide (CO) on the breath. The output is then amplified into a meaningful result by the device. The result is sent to the iCOquit® App wirelessly, allowing the meaningful result to be displayed on the user's smartphone or tablet. The App displays the reading received from the iCOquit® Smokerlyzer® on the smartphone or tablet paired with the device and based on the questions the user answers within the App relating to their smoking habits and the CO reading, they will then receive a result from the Fagerstrom Test of Nicotine Dependence. The sample method for the iCOquit® Smokerlyzer® channels the breath sample exhaled by the user into an integrated breath port on the device. This passes directly over the sensor during the test, ensuring the sensor is exposed to the gas sample for the required length of time to give an accurate reading. The user is required to hold their breath for a 15 second countdown. This is displayed via the iCOquit® App and guides the user through the process of providing a breath sample for measurement. At the end of the breath hold, the patient shall blow gently but fully into the iCOquit, exhaling as much of the breath in their lungs as possible. The reading shown on the App is the peak reading. Once a breath test has been completed the user will be navigated to a screen where they will see their CO result in PPM (parts per million) and %COHb (Carboxyhemoglobin). The reading shown on the App is the peak reading. Users are then asked Fagerstrom questions to determine their smoking status of either low, moderate or high and the result is then saved in a graph. The level of CO measured in PPM is also calculated as %COHB and displayed in the App.
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    K Number
    K201206
    Device Name
    Pivot Breath Sensor
    Manufacturer
    Carrot Inc.
    Date Cleared
    2021-06-30

    (422 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Product Code :

    CCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pivot Breath Sensor is a breath carbon monoxide monitor intended for single-user use by cigarette smokers as an educational and motivational tool to inform the user about how breath carbon monoxide levels are affected by smoking behavior. The device is not intended to be used with other combustible, inhaled products.
    Device Description
    The Pivot Breath Sensor is a personal, portable, lithium ion battery powered breath carbon monoxide ("CO") monitoring device that measures the level of CO in an individual's exhaled breath. It is intended for single-user over-the-counter ("OTC") use by cigarette smokers (users) to measure CO levels in their exhaled breath. This parameter correlates closely with carboxyhemoglobin levels and with cigarette smoking behavior. Hence, the more a person smokes, the higher are their exhaled breath CO levels. The user submits a breath sample by exhaling (blowing) into the mouthpiece of the Pivot Breath Sensor which is directed over electrochemical sensors to quantify the CO level in the breath. The sensor has two buttons - a front, center button and a side button - to help with user inputs and navigation. It also has a rechargeable battery that can be charged using a micro-USB cable by plugging into USB compatible charging sources such as a computer, USB adapter for power outlet, or car USB port. The calculated CO concentration/ level of the exhaled breath is displayed to the user in whole number parts-per-million ("ppm") on the LCD screen of the sensor. The Pivot breath sensor measures and displays CO concentrations from 0 to 100 ppm. Each of the breath sample results is shown to the user with a corresponding color and a number. The color is intended to aid in giving context to the quantitative CO value, aligning with the predicate device's color coding and scientific literature. The sensor can display multiple samples as the CO log and helps to graphically show the user their relative levels of exhaled breath CO throughout the day and between days. Hence, periodic measurements of CO levels may provide users with feedback regarding their smoking exposure, thus helping them to become educated and motivated to quit smoking, as supported by reference literature.
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    K Number
    K173238
    Device Name
    ToxCO
    Manufacturer
    Bedfont Scientific Ltd
    Date Cleared
    2019-04-04

    (546 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Product Code :

    CCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ToxCO® breath Carbon Monoxide monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.
    Device Description
    The ToxCO® is a hand held exhaled breath monitor for the detection of Carbon Monoxide on the breath. The battery powered monitor uses an electrochemical sensor, designed to react specifically to carbon monoxide producing an electrical output. The output is then amplified and a microcontroller processes the signal and converts it to a meaningful displayed result on an LCD touch screen. The sample system for the ToxCO® mimics the predicate device channeling the breath sample directly over the sensor during test ensuring the sensor is exposed to the gas sample for the required length of time to give an accurate reading. The ToxCO® Monitor uses a non-patient contacting D-piece™ sampling system, with integrated bacterial and viral filter and a one-way valve, attached directly to the monitor. A patient contacting, single patient use SteriBreath™ mouthpiece is connected to the D-piece™ sampling system to perform a breath sample. The D-piece™ is designed to have minimal dead space and therefore initial dilution of the sample is reduced. The patient is required to hold their breath for a 15 second countdown. This is displayed on the LCD screen of the device. At the end of the breath hold, the patient shall blow gently but fully into the ToxCO®, exhaling as much of the breath in their lungs as possible. The reading on the display shall rise until the peak reading is held on the display. Use of the breath sampling D-piece™ and disposable SteriBreath™ mouthpiece may be impossible if the patient is unconscious or injured. In this event, a modified sampling technique can be used, which consists of a specially constructed face mask sampling system, which allows exhaled breath to be directed to the instrument's sensor for analysis. The Face mask sampling system is a single-use, pre-assembled adapter to enable a breath sample to be taken with a single use face mask, connected to the ToxCO® breath Carbon Monoxide monitor by means of a breath sampling D-piece™. The face mask sampling procedure does not require a 15 second breath hold to be performed before the test can begin. Sampling will last 60 seconds as the %COHb/ppm levels rise and then hold at the peak level. The result will be shown on the LCD monitor screen. The ToxCO® breath Carbon Monoxide monitor and accessories are used by healthcare professionals in medical institutions and healthcare environments where Carbon Monoxide exposure is suspected.
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    K Number
    K171129
    Device Name
    CO Check Pro, CO Screen
    Manufacturer
    MD Diagnostics Limited
    Date Cleared
    2018-03-02

    (319 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Product Code :

    CCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For monitoring of carbon monoxide in adult exhaled breath. They are in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. Also can be used for ambient air monitoring. For use by healthcare professionals only in professional healthcare facilities.
    Device Description
    The Carbon monoxide monitors (CO Check Pro & CO Screen) are hand held, battery powered, carbon monoxide analyzers, used for monitoring the concentration of carbon monoxide in adult exhaled breath, typically for use in smoking cessation programs and for the screening of CO poisoning. The devices are controlled via a two button kevpad with the measured parameters displayed on a simple LCD with coloured lights and an accompanying buzzer sound in response to the CO level. Electrochemical sensor technology is utilized to sample the gas and a microprocessor converts the output from the sensor into a meaningful displayed result, either as carbon monoxide in parts per million (CO) or the percentage of carboxyhaemoglobin in the blood (%COHb). The breath sampling system that attaches directly to the carbon monoxide monitors, comprises of a non-patient contacting mouthpiece adapter incorporating a one way valve to prevent cross contamination and a single use, patient contacting cardboard mouthpiece. The mouthpiece adapter maybe replaced or reused as required. The Carbon monoxide monitors are supplied non sterile for use by healthcare professionals only and can also be used for ambient air monitoring.
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    K Number
    K171408
    Device Name
    Carbon Monoxide Breath Sensor System (COBSS)
    Manufacturer
    Carrot Sense, Inc.
    Date Cleared
    2017-09-29

    (140 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Product Code :

    CCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carbon Monoxide Breath Sensor System (COBSS) is a breath carbon monoxide monitor intended for single-user use by cigarette smokers in smoking cessation programs to inform the user about how breath carbon monoxide levels are affected by smoking behavior. The device is not intended to be used with other inhaled products.
    Device Description
    The Carbon Monoxide Breath Sensor System (COBSS) is a breath carbon monoxide ("CO") monitor intended for single-user over-the-counter ("OTC") use by smokers in smoking cessation programs. The COBSS is a portable, battery-powered device that is composed of the following: - . CO Breath Sensor. A personal mobile breath sensor capable of measuring the level of CO in exhaled breath. - . Breath Sensor App. A smart phone app which displays the exhaled breath CO value to the user. The CO Breath Sensor pairs to the Breath Sensor Application ("BSA") on the smartphone via low-energy Bluetooth. Once paired, the CO Breath Sensor communicates exclusively with the user's phone and is invisible to other devices. The primary screen for the BSA is the CO Log where the most recent exhaled breath CO value in parts-per-million ("ppm") is displayed at the top of the screen. The CO measurements are color coded according to the CO level, and the length of the bar is associated with the ppm value to graphically show the user their relative levels of exhaled breath CO throughout the day and between days.
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    K Number
    K151107
    Device Name
    CoSense ETCO Monitor
    Manufacturer
    Capnia Inc
    Date Cleared
    2015-07-22

    (86 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Product Code :

    CCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoSense ETCO Monitor is indicated for the monitoring of carbon monoxide from endogenous sources (including hemolysis) and exogenous sources (including CO poisoning and smoke inhalation) in exhaled breath. The end tidal carbon monoxide level can be used for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant. It is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.
    Device Description
    The CoSense ETCO Monitor is a battery-operated carbon monoxide (CO) monitor. It uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration. The device consists of a portable unit with software controlled menu (date, time, patient identification, measurement time of monitoring), single-use nasal cannula, replaceable CO Sensor, and a battery charger / power supply.
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    K Number
    K130036
    Device Name
    COSENSE CO MONITOR
    Manufacturer
    Capnia, Inc.
    Date Cleared
    2014-01-14

    (372 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Product Code :

    CCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoSense ETCO Monitor is indicated for the monitoring of carbon monoxide from endogenous sources (including hemolysis) and exogenous sources (including CO poisoning and smoke inhalation) in exhaled breath. The end tidal carbon monoxide level can be used for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant. It is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.
    Device Description
    The CoSense ETCO Monitor is a battery-operated carbon monoxide (CO) monitor. It uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration. The device consists of a portable unit with software controlled menu (date, time, patient identification, measurement time of monitoring), single-use nasal cannula, replaceable CO Sensor, and a battery charger/power supply.
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    K Number
    K121768
    Device Name
    COSENSE
    Manufacturer
    Capnia, Inc.
    Date Cleared
    2012-10-31

    (138 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Product Code :

    CCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoSense CO Monitor is indicated for the monitoring of Carbon Monoxide from endogenous and exogenous sources in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It is for use by health professionals.
    Device Description
    The CoSense CO Monitor is a battery-operated carbon monoxide monitor. It uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration. The device consists of a portable unit with software controlled menu (date, time, patient identification, measurement time of monitoring), single-use nasal cannula, replaceable CO Sensor, and a power supply.
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    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?
    Product Code :

    CCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K080278
    Device Name
    TABATABA COTESTER
    Manufacturer
    FIM MEDICAL
    Date Cleared
    2008-11-28

    (298 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Product Code :

    CCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TABATABA® CO TESTER is for the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals.
    Device Description
    The TABATABA is a battery operated hand held carbon monoxide monitor for use as an aid in smoking cessation programs. The TABATABA is a complete tool for the prevention of the risks of active or passive smoking. It can be carried in the pocket or on the belt. The device is parametered by an internal menu (time, date, alarm threshold, measurement time of monitoring). It can be connected to a computer via an RS232 port, to record and analyze results.
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