COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
Device Facts
| Record ID | K920338 |
|---|---|
| Device Name | COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR |
| Applicant | Puritan Bennett Corp. |
| Product Code | CCL · Anesthesiology |
| Decision Date | Aug 27, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1720 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.