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510(k) Data Aggregation
K Number
K151107Device Name
CoSense ETCO Monitor
Manufacturer
Capnia Inc
Date Cleared
2015-07-22
(86 days)
Product Code
CCJ
Regulation Number
868.1430Why did this record match?
Applicant Name (Manufacturer) :
Capnia Inc
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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