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510(k) K221590

NaviCam Small Bowel Capsule Endoscopy System by Ankon Technologies Co., Ltd. — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2022
Date Received
June 2, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Gastrointestinal, Wireless, Capsule
Device Class
Class II
Regulation Number
876.1300
Review Panel
GU
Submission Type

Other clearances by Ankon Technologies Co., Ltd.

  • DEN230027 — NaviCam ProScan (December 12, 2023)

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