FDA 510(k)

LED光療設備

K 號：K162098 · 2017-01-30

申請人Li-Tek Electronic Technology Corporation

決定日期2017-01-30

產品代碼OLP

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

LED Phototherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Li-Tek Electronic Technology Corporation. It received FDA 510(k) clearance on 2017-01-30 under 510(k) number K162098. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LED Phototherapy Device?

LED Phototherapy Device is a medical device that received FDA 510(k) clearance on 2017-01-30. The listed applicant is Li-Tek Electronic Technology Corporation. The 510(k) number is K162098.

When did LED Phototherapy Device receive FDA 510(k) clearance?

LED Phototherapy Device received FDA 510(k) clearance on 2017-01-30, under 510(k) number K162098.

Who is the listed applicant for LED Phototherapy Device?

The FDA 510(k) record lists Li-Tek Electronic Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Phototherapy Device?

The FDA product code for LED Phototherapy Device is OLP.

其他以 Li-Tek Electronic Technology Corporation 為申請人之記錄

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相關器械（代碼：OLP）

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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