21 CFR 868.5300
§ 868.5300 Carbon dioxide absorbent.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.5300, § 868.5300 Carbon dioxide absorbent, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89792
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Full text
(a) Identification. A carbon dioxide absorbent is a device intended for medical purposes that consists of an absorbent material (e.g., soda lime) that is intended to remove carbon dioxide from the gases in the breathing circuit.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.