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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 K230588
Device Name Aer-O-Scope Colonoscope System
GI View Ltd.
5 Shoham St.
Ramat Gan,  IL 5251001
Applicant Contact Sharon Goldfarb
Covington & Burling LLP
One City Center, 850 Tenth St, NW
Washington, DC,  DC  20001 -4956
Correspondent Contact Kristin Davenport
Regulation Number876.1500
Classification Product Code
Date Received03/02/2023
Decision Date 08/17/2023
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