VisuBreath
Device Facts
| Record ID | K261633 |
|---|---|
| Device Name | VisuBreath |
| Applicant | Affirm Medical Technologies II, LLC |
| Product Code | CCK · Anesthesiology |
| Decision Date | Jul 14, 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.
