Device |
humidifier, respiratory, mask (direct patient interface) |
Regulation Description |
Respiratory gas humidifier. |
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. |
Physical State |
A simple mask that is placed over the patient's nose and mouth, and held in place with an elastic band around the back of the head. |
Technical Method |
Non-invasive heat-exchange device |
Target Area |
Patient's nose/mouth area. |
Regulation Medical Specialty |
Anesthesiology |
Review Panel |
Anesthesiology |
Product Code | OBN |
Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
Submission Type |
510(k)
|
Regulation Number |
868.5450
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|