DeviceClearance

Product code OBN— Anesthesiology

HEALTH MASK

Classification name
Humidifier, Respiratory, Mask (Direct Patient Interface)
Device class
Class 2
Regulation
21 CFR 868.5450
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OBN under 21 CFR 868.5450, via openFDA

Market context for product code OBN

FDA has cleared 1 device under product code OBN, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OBN

Recent clearances under product code OBN

Data sourced from openFDA. This site is unofficial and independent of the FDA.