OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)
Device Facts
| Record ID | K941793 |
|---|---|
| Device Name | OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) |
| Applicant | Mountain Medical Equipment, Inc. |
| Product Code | CCL · Anesthesiology |
| Decision Date | Jun 21, 1995 |
| 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.
