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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K220007
Device Name Pure-Vu EVS System
Applicant
Motus GI Medical Technologies Ltd.
22 Keren Ha'yesod Str.
Tirat Carmel,  IL 3902638
Applicant Contact Mark Pomeranz
Correspondent
Motus GI Medical Technologies Ltd.
22 Keren Ha'yesod Str.
Tirat Carmel,  IL 3902638
Correspondent Contact Mark Pomeranz
Regulation Number876.1500
Classification Product Code
FDF  
Date Received01/04/2022
Decision Date 02/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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