FDA 510(k)

紫外線治療系統

K 號：K191571 · 2020-02-06

申請人Xuzhou Yongkang Electronic Science Technology Co., Ltd.

決定日期2020-02-06

產品代碼FTC

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

UV Radiation Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Yongkang Electronic Science Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-02-06 under 510(k) number K191571. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UV Radiation Treatment System?

UV Radiation Treatment System is a medical device that received FDA 510(k) clearance on 2020-02-06. The listed applicant is Xuzhou Yongkang Electronic Science Technology Co., Ltd.. The 510(k) number is K191571.

When did UV Radiation Treatment System receive FDA 510(k) clearance?

UV Radiation Treatment System received FDA 510(k) clearance on 2020-02-06, under 510(k) number K191571.

Who is the listed applicant for UV Radiation Treatment System?

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

What is the FDA product code for UV Radiation Treatment System?

The FDA product code for UV Radiation Treatment System is FTC.

其他以 Xuzhou Yongkang Electronic Science Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：FTC）

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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