100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
Device Facts
| Record ID | K010382 |
|---|---|
| Device Name | 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I |
| Applicant | Sensidyne, Inc. |
| Product Code | CCL · Anesthesiology |
| Decision Date | Mar 1, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
