K261633
- 510(k) number
- K261633
- Device name
- VisuBreath
- Applicant
- Affirm Medical Technologies II, LLC CA · US
- Product code
- CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Decision date
- 2026-07-14
- Date received
- 2026-05-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K261633.pdf
Official FDA record: K261633
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.