21 C.F.R. § 878.5080

Current through September 30, 2024
Section 878.5080 - Air-handling apparatus accessory
(a)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.
(b)Classification. 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 .

21 C.F.R. §878.5080

84 FR 14870, Apr. 12, 2019
84 FR 14870, 5/13/2019