What Is It?
To assist in maintaining an open airway.
How Is PHS Classified?
Oral Airway Assist is FDA product code PHS, Class 1, 21 CFR 868.5110.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.