21 CFR 868.1575 - Gas collection vessel.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart B [§ 868.1030 - § 868.1975]

§ 868.1575 - Gas collection vessel.

(a) Identification. A gas collection vessel is a container-like device intended to collect a patient's exhaled gases for subsequent analysis. It does not include a sampling pump.

(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 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001]

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 868.1575