QGI · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.5080
Classification
FDA Product Code
QGI
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 878.5080
Review panel
HO
Medical specialty
General, Plastic Surgery
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.