Fenom Flo FeNO Monitoring System— 510(k) K251674

Name: FDA 510(k) clearance K251674
Creator: U.S. Food and Drug Administration
Published: 2025-11-26

Substantially Equivalent

Mgc Diagnostics Corporation

FDA 510(k) clearance K251674 for Fenom Flo FeNO Monitoring System, Substantially Equivalent on 2025-11-26. Applicant: Mgc Diagnostics Corporation. Device class: 2.

Clearance details

Applicant: Mgc Diagnostics Corporation
Product code: Code MXA
Device class: Class 2
Regulation: 21 CFR 862.3080
Advisory panel: Clinical Toxicology
Date received: 2025-05-30
Decision date: 2025-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.