SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE
Device Facts
| Record ID | K863703 |
|---|---|
| Device Name | SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE |
| Applicant | Salter Labs |
| Product Code | CCK · Anesthesiology |
| Decision Date | Oct 15, 1986 |
| 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.
