21 C.F.R. § 868.5320 Reservoir bag.
Title 21 - Food and Drugs
(a) Identification. A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation. (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 38794, July 25, 2001]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 868.5320 Reservoir bag.
