Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1640](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1640) → BSE — Analyzer, Gas, Helium, Gaseous-Phase

# BSE · Analyzer, Gas, Helium, Gaseous-Phase

_Anesthesiology · 21 CFR 868.1640 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE

## Overview

- **Product Code:** BSE
- **Device Name:** Analyzer, Gas, Helium, Gaseous-Phase
- **Regulation:** [21 CFR 868.1640](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1640)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K903939](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE/K903939.md) | PANDA HELIUM GAS ANALYZER | Medical Associated Services, Inc. | Jan 3, 1991 | SESE |
| [K843843](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE/K843843.md) | HE TEST | Erich Jaeger, Inc. | Dec 4, 1984 | SESE |
| [K841858](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE/K841858.md) | SPIROLOOP | Datamed, Inc. | Jul 11, 1984 | SESE |

## Top Applicants

- Datamed, Inc. — 1 clearance
- Erich Jaeger, Inc. — 1 clearance
- Medical Associated Services, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE)

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