Product code QGI

Device name

Air-Handling Apparatus Accessory

Medical specialty

General, Plastic Surgery

Device class

1

Regulation number

878.5080

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches.

Source

FDA openFDA device classification dataset