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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 K192662
Device Name CapsoCam Plus (SV-3) Capsule Endoscopy System
Applicant
CapsoVision, Inc.
18805 Cox Avenue Suite 250
Saratoga,  CA  95070
Applicant Contact Azimun Jamal
Correspondent
CapsoVision, Inc.
18805 Cox Avenue Suite 250
Saratoga,  CA  95070
Correspondent Contact Azimun Jamal
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received09/25/2019
Decision Date 02/14/2020
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
Recalls CDRH Recalls
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