Title 21: Food and Drugs
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/ PART 868 - ANESTHESIOLOGY DEVICES
/ Subpart F - Therapeutic Devices / § 868.5675 Rebreathing device.
§ 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.