CFR
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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.
Code of Federal Regulations
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