21 CFR 868.5620 — Mouthpiece, Breathing
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5620
Identification
A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.
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 § 868.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BYP | Mouthpiece, Breathing | 1 | 25 |
