Mgc Diagnostics Corporation · Class II · Cleared Nov 26, 2025
| K-number | K251674 |
| Device name | Fenom Flo FeNO Monitoring System |
| Applicant | Mgc Diagnostics Corporation |
| Product code | MXA |
| Device class | Class II |
| Decision date | Nov 26, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 862.3080 |
The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →
View the full FDA submission: accessdata.fda.gov