21 CFR 868.5580 — Mask, Oxygen
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5580
Identification
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
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 |
|---|---|---|---|---|
| BYG | Mask, Oxygen | 1 | 55 |
