Product code PRK

Device name

Device Indicating An Exhalation Event

Medical specialty

Anesthesiology

Device class

2

Regulation number

868.2375

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

To provide visual indication of each exhalation event

Source

FDA openFDA device classification dataset