Product code PHS

Device name

Oral Airway Assist

Medical specialty

Anesthesiology

Device class

1

Regulation number

868.5110

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

To assist in maintaining an open airway.

Source

FDA openFDA device classification dataset