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510(k) Data Aggregation

    K Number
    K143127
    Device Name
    CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
    Date Cleared
    2015-02-13

    (105 days)

    Product Code
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    DISPO-MED (MALAYSIA) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor. Environment of use - hospital, sub-acute, and pre-hospital settings Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.
    Device Description
    Dispo-Med has designed a series of exhaled gas sampling devices. They include: - Nasal cannula styles that can provide supplemental O2 and sample exhaled gases - Gas sampling only devices which sample the patient's exhaled gas at the nares or in the circuit All of the devices have the same indications for use and therefore can be combined into a single submission. We will present several different configurations which have been tested and compared to several predicates. Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling design connect to the monitor via a standard luer fitting, whether it is a female or male fitting.
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