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510(k) Data Aggregation

    K Number
    K072014
    Device Name
    VITASCORE
    Manufacturer
    VITASCORE B.V.
    Date Cleared
    2007-11-08

    (108 days)

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

    VITASCORE B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vitascore software is a computer program, intended to be used as an aid for the diagnosis of sleep and respiratory disorders. The Vitascore software is intended to be used for analysis (semi-automatic and manual rescoring), display (similar to the use of a traditional paper based polygraph), redisplay (retrieve), summarize, to generate User defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders. Vitascore is to be used under supervision of a physician.
    Device Description
    Vitascore is a software program to - score respiratory events - score sleep stages and arousal - indicate markers as for lights off/on - produce customizable statistical reports. Vitascore acts on - long-term recordings that include all physiological signals that are required for clinical PolySomnoGraphy according to established standards for subsequent - diagnosis of sleep- and sleep-related disorders. Vitascore includes - a workflow concept to handle the processing of sleep recordings - optionally: automatic pre-scoring of respiratory events and sleep and arousal and EEG frequency analysis. This pre-analysis yields particular summary trend curves that facilitate the manual re-scoring.
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