21 CFR 868.2610 — Gauge, Gas Pressure, Cylinder/Pipeline
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2610
Identification
A gas pressure gauge (e.g., bourdon tube pressure gauge) is a device intended for medical purposes that is used to measure gas pressure in a medical gas delivery system.
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 |
|---|---|---|---|---|
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline | 1 | 4 | |
| PXE | Pressure Monitoring (Air/Gas) Kit | 1 | 0 |
