GF-310R Multigas Unit (GF-310R)
Device Facts
| Record ID | K251641 |
|---|---|
| Device Name | GF-310R Multigas Unit (GF-310R) |
| Applicant | Nihon Kohden Corporation |
| Product Code | CCK · Anesthesiology |
| Decision Date | Aug 12, 2026 |
| 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.
