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510(k) Data Aggregation

    K Number
    K112822
    Device Name
    SLEEPSTRIP II
    Manufacturer
    S.L.P LTD.
    Date Cleared
    2011-12-27

    (90 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    S.L.P LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SleepStrip II is intended to measure apnea/hyponea events during sleep for the purpose of prescreening patients for sleep apnea syndrome. The device is intended to be used by adult patients as prescribed by a physician in either home, hospital or facility use settings.
    Device Description
    The SleepStrip II is formed like a soft plastic "strip" or patch which is adhesively applied on the face under the nose for one night sleep. The SleepStrip II device comprises the following four main components: 1. Flexible body. 2. Sensor and signal acquisition and analysis hardware and firmware. 3. Battery as a power source. 4. A result display element. The SleepStrip II is designed to show a Sleep Apnea Syndrome (SAS) study results. It includes sensors, hardware and software to facilitate a sleep apnea screening study at the patient's home over one night sleep (under prescription). The SleepStrip II, detects and counts respiratory events (apneas and hypopneas) in real time.
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