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510(k) Data Aggregation
K Number
K131285Device Name
SONOSENTRY
Manufacturer
ISONEA LTD
Date Cleared
2014-08-19
(470 days)
Product Code
PHZ
Regulation Number
868.1900Why 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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