OBN — Humidifier, Respiratory, Mask (Direct Patient Interface) Class II
FDA product code OBN covers "Humidifier, Respiratory, Mask (Direct Patient Interface)", a Class II medical device regulated under 21 CFR 868.5450. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OBN
- Device Class
- Class II
- Regulation Number
- 868.5450
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K070467 | polar wrap | HEALTH MASK | April 17, 2007 |