FDA 510(k)

光动力疗法（PDT）设备

K号: K200751 · 2020-05-21

申请人Shangdong Huamei Technology Co., Ltd.

决定日期2020-05-21

产品代码GEX

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决定实质等同

器械摘要

Photodynamic Therapy (PDT) Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Shangdong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K200751. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Photodynamic Therapy (PDT) Equipment?

Photodynamic Therapy (PDT) Equipment is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Shangdong Huamei Technology Co., Ltd.. The 510(k) number is K200751.

When did Photodynamic Therapy (PDT) Equipment receive FDA 510(k) clearance?

Photodynamic Therapy (PDT) Equipment received FDA 510(k) clearance on 2020-05-21, under 510(k) number K200751.

Who is the listed applicant for Photodynamic Therapy (PDT) Equipment?

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

What is the FDA product code for Photodynamic Therapy (PDT) Equipment?

The FDA product code for Photodynamic Therapy (PDT) Equipment is GEX. This falls under the Gastroenterology category.

列明Shangdong Huamei Technology Co., Ltd.为申报人的其他记录

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