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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name magnetically maneuvered capsule endoscopy system
De Novo Number DEN190037
Device Name NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
Requester
anx robotica, inc.
8 the green, ste a
dover,  DE  19901
Contact david duan
Regulation Number876.1310
Classification Product Code
QKZ  
Date Received08/13/2019
Decision Date 05/22/2020
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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