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U.S. Department of Health and Human Services

Product Classification

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Device abnormal breath sound device
Definition The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
Physical State An electronic device
Technical Method It is a hand-held electronic measurement device that utilizes an acoustic sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea for the presence of breath sounds such as wheeze.
Target Area Trachea
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodePHZ
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.1900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons