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510(k) Data Aggregation
K Number
K171408Device Name
Carbon Monoxide Breath Sensor System (COBSS)
Manufacturer
Carrot Sense, Inc.
Date Cleared
2017-09-29
(140 days)
Product Code
CCJ
Regulation Number
868.1430Why did this record match?
Applicant Name (Manufacturer) :
Carrot Sense, Inc.
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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