21 CFR 868.5975
§ 868.5975 Ventilator tubing.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.5975, § 868.5975 Ventilator tubing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89850
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Full text
(a) Identification. Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.
(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.