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) → BXH — Gauge, Gas Pressure, Cylinder/Pipeline

# BXH · Gauge, Gas Pressure, Cylinder/Pipeline

_Anesthesiology · 21 CFR 868.2610 · Class 1_

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

## Overview

- **Product Code:** BXH
- **Device Name:** Gauge, Gas Pressure, Cylinder/Pipeline
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K942645](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXH/K942645.md) | B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG | B & F Medical Products, Inc. | Jul 27, 1994 | SESE |
| [K853040](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXH/K853040.md) | PRESSURE GAUGE | Erie Medical | Oct 10, 1985 | SESE |
| [K843212](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXH/K843212.md) | LOW PRESSURE ALARM FOR OXYGEN CYLINDER | Hospitak, Inc. | Sep 19, 1984 | SESE |
| [K770614](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXH/K770614.md) | MONITOR, GAS MANIFOLD | Dynatech Cryomedical Co. | Apr 7, 1977 | SESE |

## Top Applicants

- B & F Medical Products, Inc. — 1 clearance
- Dynatech Cryomedical Co. — 1 clearance
- Erie Medical — 1 clearance
- Hospitak, Inc. — 1 clearance

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

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