Product Classification

• Device: device indicating an exhalation event
• Regulation Description: Breathing frequency monitor.
• Definition: To provide visual indication of each exhalation event
• Physical State: The device includes a thermistor that could detect the temperature change of breath. Supplemental oxygen could also be provided.
• Technical Method: The device measures the time period between the current and previous exhalation and illuminates a different light during the exhalation that reflects the interval of time between breaths. This device does not calculate breath rate, e.g., breath rate per minute.
• Target Area: oral/nasal area, face
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: PRK
• 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: 868.2375
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• 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