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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 Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type 510(k)
Regulation Number 868.1900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible