Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K210270 |
Device Name |
Medical Endoscope Image Processing System |
Applicant |
Jiangsu Jiyuan Medical Technology Co., Ltd. |
No.48 CECEP (Taizhou) Environmental Protection Technology |
Industry Park, No. 59 Meilan Road Hai |
Jiangsu,
CN
225300
|
|
Applicant Contact |
Zong Yunfeng |
Correspondent |
Microkn Business Consulting (Shanghai) Co., Ltd |
Room 1219, Block A, No 3699, Gonghexin Road, Jingan District |
Shanghai,
CN
200435
|
|
Correspondent Contact |
Yuling Chen |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 02/01/2021 |
Decision Date | 10/01/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|