Product Classification

• Device: humidifier, respiratory, mask (direct patient interface)
• Regulation Description: Respiratory gas humidifier.
• Definition: Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.
• Physical State: A simple mask that is placed over the patient's nose and mouth, and held in place with an elastic band around the back of the head.
• Technical Method: Non-invasive heat-exchange device
• Target Area: Patient's nose/mouth area.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: OBN
• 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: 868.5450
• 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

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