The following data is part of a premarket notification filed by Jiangsu Jiyuan Medical Technology Co., Ltd. with the FDA for Medical Endoscope Image Processing System.
| Device ID | K210270 |
| 510k Number | K210270 |
| Device Name: | Medical Endoscope Image Processing System |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Jiangsu Jiyuan Medical Technology Co., Ltd. No.48 CECEP (Taizhou) Environmental Protection Technology Industry Park, No. 59 Meilan Road Hai Jiangsu, CN 225300 |
| Contact | Zong Yunfeng |
| Correspondent | Yuling Chen Microkn Business Consulting (Shanghai) Co., Ltd Room 1219, Block A, No 3699, Gonghexin Road, Jingan District Shanghai, CN 200435 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973672290028 | K210270 | 000 |
| 16973672290011 | K210270 | 000 |
| 16973672290004 | K210270 | 000 |
| 06973672290038 | K210270 | 000 |
| 06973672290021 | K210270 | 000 |
| 06973672290014 | K210270 | 000 |
| 06973672290007 | K210270 | 000 |
| 06973672290410 | K210270 | 000 |