21 CFR § 868.5860
Pressure tubing and accessories
June 25, 2020
(a) Identification. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.
(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 38796, July 25, 2001]