FDA 510(k)

3系列 NeoLux

K 號：K230382 · 2023-03-24

決定日期2023-03-24

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 NeoLux is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Co.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K230382. 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 NeoLux?

3 Series NeoLux is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Daavlin Distributing Co.. The 510(k) number is K230382.

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

3 Series NeoLux received FDA 510(k) clearance on 2023-03-24, under 510(k) number K230382.

Who is the listed applicant for 3 Series NeoLux?

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

What is the FDA product code for 3 Series NeoLux?

The FDA product code for 3 Series NeoLux is FTC.

其他以 Daavlin Distributing Co. 為申請人之記錄

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