21 CFR 868.5590 — Mask, Scavenging
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5590
Identification
A scavenging mask is a device positioned over a patient's nose to deliver anesthetic or analgesic gases to the upper airway and to remove excess and exhaled gas. It is usually used during dentistry.
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 |
|---|---|---|---|---|
| KHA | Mask, Scavenging | 1 | 1 |