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510(k) Data Aggregation

    K Number
    K150685
    Device Name
    Skynector CPAP Mask
    Date Cleared
    2015-08-24

    (160 days)

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

    SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed. The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment.
    Device Description
    The Skynector CPAP masks are designed based on human facial shape and structure, and the operating characteristics during application, they are injection mold of hard PC plastic and soft silicone rubber materials, with high level of air tightness, convenient operation and comfortable to wear, etc. They are used for the interfacing devices that are used to provide users with Continuous Positive Airway Pressure (CPAP) ventilation or biphasic positive airway pressure (BiPAP) ventilation treatment.
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