Endofresh Digestive Endoscopy System

Gastroscope And Accessories, Flexible/rigid

HuiZhou Xzing Technology Co., Ltd.

The following data is part of a premarket notification filed by Huizhou Xzing Technology Co., Ltd. with the FDA for Endofresh Digestive Endoscopy System.

Pre-market Notification Details

Device IDK192704
510k NumberK192704
Device Name:Endofresh Digestive Endoscopy System
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant HuiZhou Xzing Technology Co., Ltd. 4th Floor, Building D, S-16-2 Southern Park HuiNan Hi-tech Industrial Park Huizhou,  CN 516000
ContactYonglin Ni
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai,  CN 200120
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-27
Decision Date2020-09-02

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