21 C.F.R. § 868.5310

Carbon dioxide absorber.

Last amended: 2016Year: 2026Length: 90 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 868.5310 (2026)

(a) Identification. A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain. (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 § 868.9. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001]
Cross-references to the CFR
868.9.
21 C.F.R. § 868.5310: Carbon dioxide absorber. | Justis AI