FDA 510(k)

光動療法設備

K 號：K200751 · 2020-05-21

申請人Shangdong Huamei Technology Co., Ltd.

決定日期2020-05-21

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

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