FDA 510(k)

3系列光療儀器

K 號：K153749 · 2016-06-30

決定日期2016-06-30

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

3 Series Phototherapy Unit is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Company. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K153749. 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 3 Series Phototherapy Unit?

3 Series Phototherapy Unit is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Daavlin Distributing Company. The 510(k) number is K153749.

When did 3 Series Phototherapy Unit receive FDA 510(k) clearance?

3 Series Phototherapy Unit received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153749.

Who is the listed applicant for 3 Series Phototherapy Unit?

The FDA 510(k) record lists Daavlin Distributing Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3 Series Phototherapy Unit?

The FDA product code for 3 Series Phototherapy Unit is FTC.

其他以 Daavlin Distributing Company 為申請人之記錄

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K182215ClearLink 控制光療設備

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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官方來源

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