21 CFR 868.5330 - Breathing gas mixer.

Regulations last checked for updates: Feb 12, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart F [§ 868.5090 - § 868.5995]

§ 868.5330 - Breathing gas mixer.

(a) Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

(b) Classification. Class II (performance standards).

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 47 FR 31142, July 16, 1982, unless otherwise noted.

cite as: 21 CFR 868.5330