BSE · Analyzer, Gas, Helium, Gaseous-Phase
Anesthesiology · 21 CFR 868.1640 · Class 2
Overview
| Product Code | BSE |
|---|---|
| Device Name | Analyzer, Gas, Helium, Gaseous-Phase |
| Regulation | 21 CFR 868.1640 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | PANDA HELIUM GAS ANALYZER | Medical Associated Services, Inc. | Jan 3, 1991 | SESE |
| K843843 | HE TEST | Erich Jaeger, Inc. | Dec 4, 1984 | SESE |
| K841858 | SPIROLOOP | Datamed, Inc. | Jul 11, 1984 | SESE |
Top Applicants
- Datamed, Inc. — 1 clearance
- Erich Jaeger, Inc. — 1 clearance
- Medical Associated Services, Inc. — 1 clearance
