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    K Number
    K071915
    Device Name
    CPAP MASK
    Manufacturer
    ARCIMED LABORATORIES LLC
    Date Cleared
    2008-05-14

    (308 days)

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

    ARCIMED LABORATORIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient interface, face mask, for use with CPAP and bi-level systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port). Single use only < 24 hours.
    Device Description
    The proposed patient interface face mask incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use. Adhesive foam to seal to the patient face. One size - medium. Models with and without Integral fixed leak (exhalation) port.
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