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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-monoxide, gaseous-phase
510(k) Number K211918
Device Name iCOquit® Smokerlyzer®
Applicant
Bedfont Scientific Ltd
Station Road, Harrietsham
Maidstone,  GB ME17 1JA
Applicant Contact Louise Bateman
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received06/21/2021
Decision Date 12/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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