QGI · Air-Handling Apparatus Accessory
General, Plastic Surgery · 21 CFR 878.5080 · Class 1
Overview
| Product Code | QGI |
|---|---|
| Device Name | Air-Handling Apparatus Accessory |
| Regulation | 21 CFR 878.5080 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
