LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    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?
    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.
    Ask a Question
    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?
    Applicant Name (Manufacturer) :

    Capnia, Inc.

    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.
    Ask a Question

    Page 1 of 1