C-IT
Device Facts
| Record ID | K000520 |
|---|---|
| Device Name | C-IT |
| Applicant | Bregas AB |
| Product Code | CCK · Anesthesiology |
| Decision Date | May 16, 2000 |
| 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.
