GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
Device Facts
| Record ID | K943824 |
|---|---|
| Device Name | GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION |
| Applicant | Ametek, Inc. |
| Product Code | CCL · Anesthesiology |
| Decision Date | Nov 1, 1996 |
| 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.
