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510(k) Data Aggregation

    K Number
    K222262
    Device Name
    Sunrise
    Manufacturer
    Sunrise SA
    Date Cleared
    2022-12-22

    (147 days)

    Product Code
    QRS
    Regulation Number
    868.2376
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sunrise SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.
    Device Description
    The Sunrise device is a cloud-based software device that analyzes data from a sensor (Sunrise sensor 1 or Sunrise sensor 2) placed on the patient's chin. The device detects respiratory events, identifies sleep stages and position. The device generates sleep parameters, e.g. apnea hypopnea index "Sunrise AHI", and position discrete states. Data collected by the device is integrated in a report for further interpretation by the healthcare provider.
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