21 CFR 868.2700 — Regulator, Pressure, Gas Cylinder
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2700
Identification
A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
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 |
|---|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | 1 | 55 | |
| ECX | Cylinder, Compressed Gas, And Valve | 1 | 13 |
