K251674
- 510(k) number
- K251674
- Device name
- Fenom Flo FeNO Monitoring System
- Applicant
- Mgc Diagnostics Corporation MN · US
- Product code
- MXA — System, Test, Breath Nitric Oxide
- Decision date
- 2025-11-26
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251674.pdf
Official FDA record: K251674
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.