QGI

Air-Handling Apparatus Accessory

Product code

QGI

Device name

Air-Handling Apparatus Accessory

Device class

Class 1

21 CFR

21 CFR 878.5080

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K) Exempt

FDA classification 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.

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