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510(k) Data Aggregation
K Number
K211918Device Name
iCOquit® Smokerlyzer®
Manufacturer
Bedfont Scientific Ltd
Date Cleared
2021-12-21
(183 days)
Product Code
CCJ
Regulation Number
868.1430Why did this record match?
Applicant Name (Manufacturer) :
Bedfont Scientific Ltd
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
K203695Device Name
NObreath®
Manufacturer
Bedfont Scientific Ltd
Date Cleared
2021-12-17
(364 days)
Product Code
MXA
Regulation Number
862.3080Why did this record match?
Applicant Name (Manufacturer) :
Bedfont Scientific Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NObreath® is a portable. non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels.
The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society.
NObreath® is intended for children, 7- 17 years, and older. NObreath® 12 second test mode is for age 7 and up
NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test.
FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti- inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.
NObreath® should not be used in critical care, emergency care or in anesthesiology.
Device Description
NObreath® is a portable system for the non-invasive, quantitative measurement of the fraction of exhaled nitric oxide (NO) in expired human breath (FeNO). The NObreath® system is comprised of the main unit with AC adapter, a rechargeable battery, an electrochemical NO sensor, disposable patient mouthpiece with filter. The device can connect to the PC via a standard USB cable or wirelessly via Bluetooth.
For testing, the patient inhales deeply and slowly exhales for 10 or 12 seconds through the patient filter. In approximately 12 seconds the NO concentration is displayed in parts per billion (ppb). Results are processed using dedicated software. The device has built-in system control procedures and a calibration to be performed every 12 months.
Wireless Bluetooth Low Energy (BLE) is used as a means of communication between the monitor and FeNOchart™ software running on a PC. The FeNOchart™ software is a charting program that retrospectively collects data from the NObreath® monitor when it is not monitoring. It is not time critical, there are no alarms
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K Number
K173238Device Name
ToxCO
Manufacturer
Bedfont Scientific Ltd
Date Cleared
2019-04-04
(546 days)
Product Code
CCJ
Regulation Number
868.1430Why did this record match?
Applicant Name (Manufacturer) :
Bedfont Scientific Ltd
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
K082315Device Name
EC50 MICRO+ SMOKERLYZER
Manufacturer
BEDFONT SCIENTIFIC LTD.
Date Cleared
2010-02-01
(537 days)
Product Code
CCJ, DLJ, LAS
Regulation Number
868.1430Why 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
K070259Device Name
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
Manufacturer
BEDFONT SCIENTIFIC LTD.
Date Cleared
2008-02-21
(391 days)
Product Code
CCJ
Regulation Number
868.1430Why 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
K000962Device Name
PICO SMOKERLYZER, MODEL EC-50
Manufacturer
BEDFONT SCIENTIFIC LTD.
Date Cleared
2000-04-20
(27 days)
Product Code
CCJ
Regulation Number
868.1430Why 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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