PHS · Oral Airway Assist
Anesthesiology · 21 CFR 868.5110 · Class 1
Overview
| Product Code | PHS |
|---|---|
| Device Name | Oral Airway Assist |
| Regulation | 21 CFR 868.5110 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
