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510(k) Data Aggregation

    K Number
    K150365
    Device Name
    Cloud9 System
    Date Cleared
    2015-07-21

    (159 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    inSleep Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cloud9® System is indicated for use by adults to reduce or eliminate simple snoring. The Cloud9® System maintains a continuous, positive low-pressure in the airway. The device is designed for prescription home use.
    Device Description
    The Cloud9® System is a device for delivery of low levels of continuous positive airway pressure (CPAP) that can be used by people who wish to reduce or eliminate their snoring. lts main components include the airflow unit (AFU) and custom nasal mask interface, called the NiteCap™. The Cloud9® System delivers CPAP at low pressures ranging from 2 to 4 cmH₂O, via a nasal interface. The blower generating the airstream is controlled continuously based on pressure measurements at the nasal interface to maintain the pressure at the nose of the user constant ("CPAP"). Its performance is similar to currently used CPAP devices.
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