SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
Device Facts
| Record ID | K000700 |
|---|---|
| Device Name | SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR |
| Applicant | Sensidyne, Inc. |
| Product Code | CCL · Anesthesiology |
| Decision Date | Aug 31, 2000 |
| 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.
