21 CFR 868.5110 — Airway, Oropharyngeal, Anesthesiology
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5110
Identification
An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent 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 |
|---|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 57 | |
| PHS | Oral Airway Assist | 1 | 0 |
