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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Breath Nitric Oxide
510(k) Number K251674
Device Name Fenom Flo™ FeNO Monitoring System
Applicant
Mgc Diagnostics Corporation
350 Oak Grove Pkwy.
St. Paul,  MN  55127
Applicant Contact Arathi Sundaresan
Correspondent
Pathmaker FDA Law, PLLC
1450 Lilac Dr. N
Suite 270
Minneapolis,  MN  55422
Correspondent Contact Amy Fowler
Regulation Number862.3080
Classification Product Code
MXA  
Date Received05/30/2025
Decision Date 11/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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