21 CFR 868.5350 — Catheter, Nasal, Oxygen
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5350
Identification
A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen.
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 |
|---|---|---|---|---|
| BZB | Catheter, Nasal, Oxygen | 1 | 8 |
