OBN

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Humidifier, Respiratory, Mask (Direct Patient Interface)

Device class

Class II (moderate risk)

Regulation

21 CFR 868.5450

Medical specialty

Anesthesiology

Flags

Third-party review eligible

FDA 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.

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