PRK

Device Indicating An Exhalation Event

Product code

PRK

Device name

Device Indicating An Exhalation Event

Device class

Class 2

21 CFR

21 CFR 868.2375

Medical specialty

Anesthesiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

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

FDA classification definition

To provide visual indication of each exhalation event

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