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510(k) Data Aggregation

    K Number
    K170071
    Device Name
    SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer
    Manufacturer
    Sleep Group Solutions
    Date Cleared
    2017-11-09

    (304 days)

    Product Code
    BXQ, BXO
    Regulation Number
    868.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sleep Group Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECCOVISION™ is intended to measure the upper respiratory airway by means of acoustic reflection.
    Device Description
    The Eccovision™ device is used to obtain an objective measurement of the upper respiratory airway. The device uses acoustic signal processing technology to provide graphical representation of the airway patency as a function of distance from the airway opening. The system consists of a control unit (which connects to customer owned personal computer), and software application, wave tube (one each for the Pharyngometer and Rhinometer) and electronic platform, mouthpieces and nose tips and filter strips. The device performs a dynamic test that determines the dimension of the oral airway past the glottis while the patient is breathing thorough either the mouthpiece or nose tip. A customer provided computer with the loaded Eccovision™ application software then processes the incident and reflected sound signals provides an area-distance curve representing the lumen together with minimal crosssectional area and volume. A measurement is obtained by passing a signal along a probe positioned in the mouth or nose then recover a signal by use of two (2) microphones in the wave tube. The signal is processed by the software and displayed on a screen or relayed to a printer, detailing the cross-sectional area of the airway as a function of distance from the teeth.
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