21 CFR 868.5675 — Device, Rebreathing
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5675
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BYW | Device, Rebreathing | 1 | 2 |
