OBN

Humidifier, Respiratory, Mask (Direct Patient Interface)

Product code

OBN

Device name

Humidifier, Respiratory, Mask (Direct Patient Interface)

Device class

Class 2

21 CFR

21 CFR 868.5450

Medical specialty

Anesthesiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).