OBNClass II
Humidifier, Respiratory, Mask (direct Patient Interface)
Anesthesiology · 21 CFR 868.5450
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.
MDR events2All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury1
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code