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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 K203695
Device Name NObreath®
Applicant
Bedfont Scientific, Ltd.
Station Rd., Harrietsham
Maidstone, Kent,  GB ME17 1JA
Applicant Contact Louise Bateman
Correspondent
Bedfont Scientific, LLC C/O Promedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number862.3080
Classification Product Code
MXA  
Date Received12/18/2020
Decision Date 12/17/2021
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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