QGI — Air-Handling Apparatus Accessory Class I
FDA product code QGI covers "Air-Handling Apparatus Accessory", a Class I medical device regulated under 21 CFR 878.5080. Submissions are reviewed by the General, Plastic Surgery panel.
Classification Details
- Product Code
- QGI
- Device Class
- Class I
- Regulation Number
- 878.5080
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.