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510(k) Data Aggregation

    K Number
    K131285
    Device Name
    SONOSENTRY
    Manufacturer
    ISONEA LTD
    Date Cleared
    2014-08-19

    (470 days)

    Product Code
    PHZ
    Regulation Number
    868.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISONEA LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SonoSentry™ WheezeRate™ Detector is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate™ in adults and children (2 years and older). WheezeRate™ represents the percentage of abnormal breath sound detected during the measurement time. A licensed health care professional's advice is required to understand the meaning and importance of the SonoSentry™ readings.
    Device Description
    The SonoSentry™ WheezeRate™ Detector is a hand-held electronic measurement device that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze breath sounds at the trachea for the presence of continuous adventitious breath sounds/CABS. The device calculates and outputs a WheezeRate™ based on the amount of abnormal breath sounds detected in a given time. The device is designed for use in adults and children (ages 2 years and older). The SonoSentry™ WheezeRate™ Detector consists of: - . An acoustic contact sensor - . An air-coupled electret microphone for ambient noise reiection module - LCD screen to display measurement results . - . 4 user buttons - . Signal conditioning and digitization PCB - Dedicated DSP . - . SDRAM memory - . Embedded software
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