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510(k) Data Aggregation
K Number
K112102Device Name
MICHELE SLEEP SCORING SYSTEMS
Manufacturer
YOUNES SLEEP TECHNOLOGIES
Date Cleared
2011-12-20
(151 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
YOUNES SLEEP TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MICHELE Sleep Scoring System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders.
The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.
The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.
Device Description
The MICHELE Sleep Scoring System (MICHELE) is a software system that scans physiological data obtained during level 1 sleep studies, referred to as polysomnography (PSG) records, and applies a variety of analytical approaches to identify the occurrence of certain events that relate to the presence and type of sleep state, breathing abnormalities and limb movements. The system scores Sleep Stages, Arousals, Respiratory Events and Leg Movements. At the end of the analysis the system generates a PSG Report that includes tables and graphs typical of those generated following manual scoring of PSG records by certified technologists. The results of the automated scoring may be displayed using a PSG Scoring Viewer application, which allows manual editing of the results and generation of a revised PSG Report.
The device does not analyze data that are different from those analyzed by human scorers. It also neither interprets the results nor suggests a diagnosis.
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