PXE · Pressure Monitoring (Air/Gas) Kit
Anesthesiology · 21 CFR 868.2610 · Class 1
Overview
| Product Code | PXE |
|---|---|
| Device Name | Pressure Monitoring (Air/Gas) Kit |
| Regulation | 21 CFR 868.2610 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
