21 CFR 878.5080
§ 878.5080 Air-handling apparatus accessory.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.5080, § 878.5080 Air-handling apparatus accessory, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90485
- Permanent ID
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.