Product Classification

• 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 Code: PHZ
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc