OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER
Device Facts
| Record ID | K895780 |
|---|---|
| Device Name | OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER |
| Applicant | Datex Division Instrumentarium Corp. |
| Product Code | CCK · Anesthesiology |
| Decision Date | Nov 29, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.
