FDA 510(k)

Smoklean

K 號：K173108 · 2018-05-18

決定日期2018-05-18

產品代碼FYD

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

Smoklean is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K173108. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Smoklean?

Smoklean is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Sejong Medical Co., Ltd.. The 510(k) number is K173108.

When did Smoklean receive FDA 510(k) clearance?

Smoklean received FDA 510(k) clearance on 2018-05-18, under 510(k) number K173108.

Who is the listed applicant for Smoklean?

The FDA 510(k) record lists Sejong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smoklean?

The FDA product code for Smoklean is FYD.

其他以 Sejong Medical Co., Ltd. 為申請人之記錄

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官方來源

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