FDA 510(k)

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K-번호: K192704 · 2020-09-02

결정일2020-09-02

제품 코드FDS

자문 위원회규제 정책: medical-regulatory-v1 GU

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기기 요약

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

자주 묻는 질문

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. The listed applicant is Huizhou Xzing Technology Co., Ltd.. The 510(k) number is K192704.

When did Endofresh Digestive Endoscopy System receive FDA 510(k) clearance?

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

Who is the listed applicant for Endofresh Digestive Endoscopy System?

The FDA 510(k) record lists Huizhou Xzing Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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관련 임상시험

관련 기기 (코드: FDS)

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