Device Classification Name |
System, Imaging, Gastrointestinal, Wireless, Capsule
More FDA Info for this Device |
510(K) Number |
K221590 |
Device Name |
System, Imaging, Gastrointestinal, Wireless, Capsule |
Applicant |
ANKON Technologies Co., Ltd.
B3-2, B3-3, D3-4 Biolake, No.666, Hi-Tech Road
Wuhan 430075 CN
Other 510(k) Applications for this Company
|
Contact |
Si Feng Wang
Other 510(k) Applications for this Contact |
Regulation Number |
876.1300
More FDA Info for this Regulation Number |
Classification Product Code |
NEZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/02/2022 |
Decision Date |
12/02/2022 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
GU - Gastroenterology & Urology |
Review Advisory Committee |
GU - Gastroenterology & Urology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|