Medical Endoscope Image Processing System

Hysteroscope (and Accessories)

Jiangsu Jiyuan Medical Technology Co., Ltd.

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.

Pre-market Notification Details

Device IDK210270
510k NumberK210270
Device Name:Medical Endoscope Image Processing System
ClassificationHysteroscope (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
ContactZong Yunfeng
CorrespondentYuling Chen
Microkn Business Consulting (Shanghai) Co., Ltd Room 1219, Block A, No 3699, Gonghexin Road, Jingan District Shanghai,  CN 200435
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-01
Decision Date2021-10-01

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