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510(k) Data Aggregation

    K Number
    K171827
    Device Name
    ReddyPort NIV Access Elbow
    Manufacturer
    SMD Manufacturing, LLC
    Date Cleared
    2018-01-19

    (213 days)

    Product Code
    MNS
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMD Manufacturing, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReddyPort NIV Access Elbow is intended to provide an interface for application of CPAP or bi-level therapy. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients 7 years or older (>40lbs/18.2kg) for whom CPAP or bi-level therapy has been prescribed.
    Device Description
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