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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K212316
Device Name DoubleChek DC-1001
Applicant
Nasogastric Feeding Solutions, Ltd.
131 Mount Pleasant
Liverpool,  GB L3 5TF
Applicant Contact Mark Townend
Correspondent
Koelper Consulting, LLC
268 Biltmore Dr.
North Barrington,  IL  60010
Correspondent Contact Crystal Koelper
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/26/2021
Decision Date 09/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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