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510(k) Data Aggregation

    K Number
    K140580
    Device Name
    REVOLUTION FULLFACE MASK
    Manufacturer
    RESPIRONICS INC. (DBA PHILIPS RESPIRONICS)
    Date Cleared
    2015-01-16

    (316 days)

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

    RESPIRONICS INC. (DBA PHILIPS RESPIRONICS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revolution Full Face Mask is intended to provide an interface for continuous possitive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.
    Device Description
    The Respironics Revolution Full Face Mask consists of a frame (faceplate) with a silicone cushion and an elbow with an integral entrainment valve. The faceplate holds multiple sizes in order to exchange mask cushion sizes on one (frame) faceplate. The Revolution Full Face Mask cushion has eight exhalation vents, with four vents located on either side of the mask cushion. As a result, a separate exhalation device is not required for use of this mask. The mask has an integrated entrainment valve elbow with a two-piece polycarbonate valve body with a silicone flapper and exhalation vents located on the valve body. This feature was modified from Revolution Full Face (K082866) from a "stream-line" design however this elbow design was cleared under K073600. The design of the Revolution Full Face Mask headgear has two slide-through top strap adjustments, side and back straps, a Lower Headgear Band and a Chin Support Band. The mask is available in four sizes – small, medium, and large.
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