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510(k) Data Aggregation

    K Number
    K162192
    Device Name
    BluePro
    Manufacturer
    BlueSom
    Date Cleared
    2016-12-15

    (133 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BlueSom

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BluePro® is a mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
    Device Description
    The BluePro® oral appliance design concept is based upon the use of a standard set of upper and lower trays, referred also as splints in documentation, that are then customized for fit by a dentist. The design is commonly referred to as a Mandibular Repositioning Device (MRD).
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