21 C.F.R. § 868.5675

Current through April 30, 2024
Section 868.5675 - Rebreathing device
(a)Identification. A rebreathing device is a device that enables a patient to rebreathe exhaled gases. It may be used in conjunction with pulmonary function testing or for increasing minute 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 § 868.9 .

21 C.F.R. §868.5675

47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000