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    K Number
    K180608
    Device Name
    Lunoa System
    Manufacturer
    NightBalance BV
    Date Cleared
    2018-06-05

    (90 days)

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

    NightBalance BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lunoa System is indicated for prescription use for the treatments with positional obstructive sleep apnea with a non-supine apnea-hypopnea index <20. It records position and movement so that positional changes in sleep quality can be assessed.
    Device Description
    The Lunoa System is a rechargeable battery-operated medical device, worn around the chest in an elasticized chest strap (Figure 1), intended to keep patients with positional obstructive sleep apnea (POSA) from sleeping in the supine position. The System consists of a sensor device, chest strap, docking station, power adapter, travel case, and portal.
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