Device Classification Name |
Choledochoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K231105 |
Device Name |
Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) |
Applicant |
Shanghai AnQing Medical Instrument Co., Ltd |
3 & 4 Floor, No.2 Building, 366 Huiqing Rd |
East Zhangjiang High-Tech Park |
Shanghai,
CN
201201
|
|
Applicant Contact |
Shuwen Fan |
Correspondent |
Shanghai AnQing Medical Instrument Co., Ltd |
3 & 4 Floor, No.2 Building, 366 Huiqing Rd |
East Zhangjiang High-Tech Park |
Shanghai,
CN
201201
|
|
Correspondent Contact |
Shuwen Fan |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/19/2023 |
Decision Date | 10/17/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|