FDA 510(k)

TWBM 泵

K 號：K180115 · 2018-07-24

決定日期2018-07-24

產品代碼JCX

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

TWBM Pump is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Biomaterial Co., Ltd.. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K180115. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TWBM Pump?

TWBM Pump is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Taiwan Biomaterial Co., Ltd.. The 510(k) number is K180115.

When did TWBM Pump receive FDA 510(k) clearance?

TWBM Pump received FDA 510(k) clearance on 2018-07-24, under 510(k) number K180115.

Who is the listed applicant for TWBM Pump?

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

What is the FDA product code for TWBM Pump?

The FDA product code for TWBM Pump is JCX.

其他以 Taiwan Biomaterial Co., Ltd. 為申請人之記錄

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相關器械（代碼：JCX）

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