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U.S. Department of Health and Human Services

Product Classification

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Device abnormal breath sound device
Regulation Description Diagnostic pulmonary-function interpretation calculator.
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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia 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
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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