PANDA HELIUM GAS ANALYZER
Device Facts
| Record ID | K903939 |
|---|---|
| Device Name | PANDA HELIUM GAS ANALYZER |
| Applicant | Medical Associated Services, Inc. |
| Product Code | BSE · Anesthesiology |
| Decision Date | Jan 3, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1640 |
| Device Class | Class 2 |
Regulatory Classification
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.