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 Number | 876.1310
|
Classification Product Code |
|
Date Received | 08/13/2019 |
Decision Date | 05/22/2020 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|