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FDA 510(k)

Endofresh Digestive Endoscopy System

K-Number: K192704 · 2020-09-02

ApplicantHuizhou Xzing Technology Co., Ltd.
Decision Date2020-09-02
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endofresh Digestive Endoscopy System is a medical device manufactured by Huizhou Xzing Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-09-02 under approval number K192704. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endofresh Digestive Endoscopy System?

Endofresh Digestive Endoscopy System is a medical device that received FDA 510(k) clearance on 2020-09-02. It is manufactured by Huizhou Xzing Technology Co., Ltd.. The 510(k) number is K192704.

When was Endofresh Digestive Endoscopy System approved by the FDA?

Endofresh Digestive Endoscopy System received FDA 510(k) clearance on 2020-09-02, under approval number K192704.

What company makes Endofresh Digestive Endoscopy System?

Endofresh Digestive Endoscopy System is manufactured by Huizhou Xzing Technology Co., Ltd..

What is the FDA product code for Endofresh Digestive Endoscopy System?

The FDA product code for Endofresh Digestive Endoscopy System is FDS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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