Source document or public record
FDA 510(k) K251674 — Fenom Flo FeNO Monitoring System
FDA 510(k) index record K251674. Device: Fenom Flo FeNO Monitoring System. Applicant as listed: Mgc Diagnostics Corporation. Decision date: 2025-11-26.
Source
"device_name": "Fenom Flo FeNO Monitoring System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K251674.
Device name: Fenom Flo FeNO Monitoring System. Applicant as listed: Mgc Diagnostics Corporation.
Decision date: 2025-11-26. Decision wording: Substantially Equivalent.
Product code: MXA. Regulation: 21 CFR 862.3080. Medical specialty: Clinical Toxicology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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