21 CFR 868.5700 — Tent, Oxygen
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5700
Identification
A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.
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 |
|---|---|---|---|---|
| BYL | Tent, Oxygen | 1 | 11 | |
| FOG | Hood, Oxygen, Infant | 1 | 9 |
