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510(k) Data Aggregation

    K Number
    K200698
    Device Name
    Somnera System
    Date Cleared
    2020-06-29

    (104 days)

    Product Code
    Regulation Number
    868.5273
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESCA Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Somnera System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and during an incipient apnea. The system includes a dedicated flow generator and a patient interface; and is intended for use in the home environment. The system is to be used by adult patients weighing more than 66 lbs. (30 kg.).
    Device Description
    The Somnera System is a positive airway pressure system comprised of an airflow generator and a patient interface. The patient interface has a SmartValve™ seated in either a nasal mask or nasal pillow mask. A hose connects the valve to the generator. The mask is held in place with adjustable headgear straps. The patient interface is supplied non-sterile and intended for single patient reuse in the home environment. The Somnera System is a prescription device.
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    K Number
    DEN170089
    Device Name
    Curve Positive Airway Pressure System
    Manufacturer
    Date Cleared
    2018-06-05

    (173 days)

    Product Code
    Regulation Number
    868.5273
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESCA Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CURVE™ Positive Airway Pressure System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and also during an incipient apnea. The system includes a dedicated flow generator and a patient interface, and is intended for use in the home environment. This system is to be used by adult patients weighing more than 66 lbs (30 kg).
    Device Description
    The CURVE™ Positive Airway System is comprised of five components: a Nasal Pillow, Headgear, Valve, Hose, and Flow Generator. The CURVE™ System Airbox is a flow generator that provides airflow and pressure to the mask and delivers therapeutic pressure to the patient's airway during disordered breathing. The valve allows positive airway pressure to be generated during expiration but at the same time it (1) reduces the airflow required to provide positive airway pressure during inspiration and expiration, and (2) utilizes the patient's own breathing effort during both normal inspiration and expiration. During disordered breathing events, such as apnea or hypopnea, the valve opens to allow positive airway pressure to be provided to the patient directly from the flow generator. In addition, the valve is designed to channel excess airflow directly into the room, thereby minimizing spikes in pressure and preventing carbon dioxide rebreathing from the hose. The CURVE™ System patient interface consists of a nasal pillow mask, headgear and a hose. The nasal pillow mask includes the valve and the mask is held in contact with the patient's nares via the headgear. The nasal pillow mask is available in three sizes (small. medium and large). The hose connects the flow generator to the valve in the mask to deliver air from the flow generator to the mask. The CURVE™ System is designed to have pressurized air from the flow generator always available to provide airway support. During treatment, the flow generator is never "off" or paused. Pressurized air is always being delivered through the hose to the valve, and flows into the mask whenever there is a drop in pressure or flow rate. The CURVE™ System flow generator can only be used with the CURVE™ System patient interface and vice versa. The size and configuration of the Curve System hose and flow generator connectors are designed to prevent connection to a standard Continuous Positive Airway Pressure (CPAP) hose, mask or flow generator.
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