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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 K183192
Device Name CapsoCam Plus (SV-3)
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 Received11/19/2018
Decision Date 04/19/2019
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
Recalls CDRH Recalls
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