FDA 510(k)

DW-1C

K 號：K160761 · 2016-11-22

決定日期2016-11-22

產品代碼NEW

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

DW-1C is the device name listed in this FDA 510(k) record. The listed applicant is Dongwon Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K160761. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DW-1C?

DW-1C is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Dongwon Medical Co., Ltd.. The 510(k) number is K160761.

When did DW-1C receive FDA 510(k) clearance?

DW-1C received FDA 510(k) clearance on 2016-11-22, under 510(k) number K160761.

Who is the listed applicant for DW-1C?

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

What is the FDA product code for DW-1C?

The FDA product code for DW-1C is NEW.

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官方來源

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