SPIROLOOP
Device Facts
| Record ID | K841858 |
|---|---|
| Device Name | SPIROLOOP |
| Applicant | Datamed, Inc. |
| Product Code | BSE · Anesthesiology |
| Decision Date | Jul 11, 1984 |
| 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.
