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510(k) Data Aggregation

    K Number
    K203347
    Device Name
    Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask
    Date Cleared
    2021-07-02

    (231 days)

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

    Suzhou Yuyue Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system. -The mask is to be used by patients (weighing>30kg), intended for single patient reuse in the home environment. -The mask is intended for single-patient use in the hospital or institutional environment.
    Device Description
    These masks act as an interface for CPAP/BPAP device and deliver pressurized air to prevent apnea from occurring. The masks consist of several parts which includes frame, cushion, elbow, swivel, and headgear. The frame provides support for the mask, the cushion provides the seal, the elbow is designed to provide a vent for exhaust gas and a valve to prevent asphyxiation. The swivel can be rotated 360 degrees, which can help prevent pipe winding. The size of the connector port of the swivel is consistent with ISO standards and can be connected to any tube which conforms to the same standard. The headgear is used to fasten the mask to the face. The masks can be disassembled without any tools.
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