21 CFR § 868.5310 Anesthesiology Devices

§ 868.5310 Carbon dioxide absorber.

Current through Sep 8, 2026 · Read all of Part 868

(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]

← § 868.5300 Carbon dioxide absorbent.§ 868.5320 Reservoir bag. →