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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Gastrointestinal, Wireless, Capsule
510(k) Number K242643
Device Name CapsoCam Plus (SV-3) Capsule Endoscopy System
Applicant
CapsoVision, Inc.
18805 Cox Ave.
Suite 250
Saratoga,  CA  95070
Applicant Contact Azimun Jamal
Correspondent
CapsoVision, Inc.
18805 Cox Ave.
Suite 250
Saratoga,  CA  95070
Correspondent Contact Zane Liu
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received09/03/2024
Decision Date 12/04/2024
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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