Fenom Flo FeNO Monitoring System
K-Number: K251674 · 2025-11-26
ApplicantMgc Diagnostics Corporation
Decision Date2025-11-26
Product CodeMXA
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
Fenom Flo FeNO Monitoring System is a medical device manufactured by Mgc Diagnostics Corporation. It received FDA 510(k) clearance on 2025-11-26 under approval number K251674. The device is classified under product code MXA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fenom Flo FeNO Monitoring System?
Fenom Flo FeNO Monitoring System is a medical device that received FDA 510(k) clearance on 2025-11-26. It is manufactured by Mgc Diagnostics Corporation. The 510(k) number is K251674.
When was Fenom Flo FeNO Monitoring System approved by the FDA?
Fenom Flo FeNO Monitoring System received FDA 510(k) clearance on 2025-11-26, under approval number K251674.
What company makes Fenom Flo FeNO Monitoring System?
Fenom Flo FeNO Monitoring System is manufactured by Mgc Diagnostics Corporation.
What is the FDA product code for Fenom Flo FeNO Monitoring System?
The FDA product code for Fenom Flo FeNO Monitoring System is MXA.
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Official Source
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