21 CFR 868.5570 — Mask, Oxygen, Non-Rebreathing
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5570
Identification
A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.
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 the limitations in § 868.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KGB | Mask, Oxygen, Non-Rebreathing | 1 | 13 |
