Atlas FDA

NaviCam ProScan

FDA 510(k) clearance DEN230027 · decided 2023-12-12

Clearance details

K-number
DEN230027
Device name
NaviCam ProScan
Applicant
Ankon Technologies Co., Ltd.
Decision
Unknown
Date received
2023-04-14
Decision date
2023-12-12
Days to decision
242 days
Clearance type
Direct
Product code
QZF
Device class
2
Regulation number
876.1540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Wuhan, CN
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.