TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
Device Facts
| Record ID | K963327 |
|---|---|
| Device Name | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 |
| Applicant | Novametrix Medical Systems, Inc. |
| Product Code | CCK · Anesthesiology |
| Decision Date | Nov 20, 1996 |
| 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.
