Product code QXN

Device name

Suction Anti-Choking Device As A Second-Line Treatment

Medical specialty

Ear, Nose, Throat

Device class

2

Regulation number

874.5400

Review panel

EN

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A suction anti-choking device as a second-line treatment is intended to be used, by application of suction, to resolve choking in victims experiencing complete airway obstruction. The device is intended to be used as a second-line treatment in an emergency situation after unsuccessful use of a basic life support (BLS) choking protocol.

Source

FDA openFDA device classification dataset