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510(k) Data Aggregation
K Number
K170071Device 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
868.1800Why 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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