PMB

External Airway

Product code

PMB

Device name

External Airway

Device class

Class 2

21 CFR

21 CFR 868.5105

Medical specialty

Anesthesiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.

Definition text from the FDA device classification database (U.S. federal government work, public domain).