21 CFR 868.5550 — Mask, Gas, Anesthetic
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5550
Identification
An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.
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 |
|---|---|---|---|---|
| BSJ | Mask, Gas, Anesthetic | 1 | 51 |
