FDA 510(k)

光動治療設備

K 號：K170187 · 2017-07-28

決定日期2017-07-28

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 Device is the device name listed in this FDA 510(k) record. The listed applicant is Uvbiotek, LLC. It received FDA 510(k) clearance on 2017-07-28 under 510(k) number K170187. 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 Device?

Photodynamic Therapy Device is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Uvbiotek, LLC. The 510(k) number is K170187.

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

Photodynamic Therapy Device received FDA 510(k) clearance on 2017-07-28, under 510(k) number K170187.

Who is the listed applicant for Photodynamic Therapy Device?

The FDA 510(k) record lists Uvbiotek, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Photodynamic Therapy Device?

The FDA product code for Photodynamic Therapy Device is GEX. This falls under the Gastroenterology category.

其他以 Uvbiotek, LLC 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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