FDA 510(k)

氧光

K 號：K200104 · 2020-06-04

決定日期2020-06-04

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

Oxylight is the device name listed in this FDA 510(k) record. The listed applicant is Raja Trading Company, Inc.. It received FDA 510(k) clearance on 2020-06-04 under 510(k) number K200104. 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 Oxylight?

Oxylight is a medical device that received FDA 510(k) clearance on 2020-06-04. The listed applicant is Raja Trading Company, Inc.. The 510(k) number is K200104.

When did Oxylight receive FDA 510(k) clearance?

Oxylight received FDA 510(k) clearance on 2020-06-04, under 510(k) number K200104.

Who is the listed applicant for Oxylight?

The FDA 510(k) record lists Raja Trading Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oxylight?

The FDA product code for Oxylight is GEX. This falls under the Gastroenterology category.

其他以 Raja Trading Company, Inc. 為申請人之記錄

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K243063Myolight 微電流手柄 K202175氧光2.0

相關器械（代碼：GEX）

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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