21 CFR 878.5080 — Air-Handling Apparatus Accessory

General, Plastic Surgery (SU) · Part 878 Subpart F—Therapeutic Devices · § 878.5080

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
QGIAir-Handling Apparatus Accessory10
Innolitics

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