Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2610](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2610) → PXE — Pressure Monitoring (Air/Gas) Kit

# PXE · Pressure Monitoring (Air/Gas) Kit

_Anesthesiology · 21 CFR 868.2610 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/PXE

## Overview

- **Product Code:** PXE
- **Device Name:** Pressure Monitoring (Air/Gas) Kit
- **Regulation:** [21 CFR 868.2610](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2610)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/PXE](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/PXE)

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