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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, gastrointestinal motility (electrical)
510(k) Number K201106
Device Name IntraMarX 3D Radiopaque Marker
AnX Robotica Corp.
1047 Serpentine Ln. Suite 100, Pleasanton
Pleasanton,  CA  94566
Applicant Contact Steven Gu
Emergo Global Consulting, LLC
2500 Bee Cave Rd, Bldg 1, Suite 300
Austin,  TX  78746
Correspondent Contact Randy Jiang
Regulation Number876.1725
Classification Product Code
Date Received04/24/2020
Decision Date 05/21/2020
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