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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name magnetically maneuvered capsule endoscopy system
510(k) Number K203192
Device Name NaviCam Xpress Stomach System
Applicant
AnX Robotica Corp
1047 Serpentine Lane
Pleasanton,  CA  94566
Applicant Contact Shoshana (Shosh) Friedman
Correspondent
AnX Robotica Corp
1047 Serpentine Lane
Pleasanton,  CA  94566
Correspondent Contact Shoshana (Shosh) Friedman
Regulation Number876.1310
Classification Product Code
QKZ  
Date Received10/28/2020
Decision Date 05/04/2021
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
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