
Mgc Diagnostics Corporation
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Fenom Flo FeNO Monitoring System is an FDA 510(k)-cleared medical device (K251674) manufactured by Mgc Diagnostics Corporation. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 2025. Regulation: 8.