Air-Handling Apparatus Accessory
The Air-Handling Apparatus Accessory is a supplementary device intended for use with an air-handling apparatus for a surgical operating room, providing an interface between components or enabling electrical power switching, and includes fittings, adapters, couplers, remote switches, and footswitches. It is classified as FDA Class 1, with no premarket notification required, under regulation 878.5080 in the General and Plastic Surgery specialty. The product code is QGI. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QGI
- Device Class
- FDA class 1
- Regulation Number
- 878.5080
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.