OBN · Class II · 21 CFR 868.5450

FDA Product Code OBN: Humidifier, Respiratory, Mask (direct Patient Interface)

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.

1
Total
1
Cleared
60d
Avg days
2007
Since

FDA 510(k) Cleared Humidifier, Respiratory, Mask (direct Patient Interface) Devices (Product Code OBN)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OBN - Regulatory Context