FDA 510(k)

雷克斯醫療吸引泵

K 號：K173389 · 2018-01-30

決定日期2018-01-30

產品代碼BTA

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

Rex Medical Aspiration Pump is the device name listed in this FDA 510(k) record. The listed applicant is Rex Medical, L.P.. It received FDA 510(k) clearance on 2018-01-30 under 510(k) number K173389. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rex Medical Aspiration Pump?

Rex Medical Aspiration Pump is a medical device that received FDA 510(k) clearance on 2018-01-30. The listed applicant is Rex Medical, L.P.. The 510(k) number is K173389.

When did Rex Medical Aspiration Pump receive FDA 510(k) clearance?

Rex Medical Aspiration Pump received FDA 510(k) clearance on 2018-01-30, under 510(k) number K173389.

Who is the listed applicant for Rex Medical Aspiration Pump?

The FDA 510(k) record lists Rex Medical, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rex Medical Aspiration Pump?

The FDA product code for Rex Medical Aspiration Pump is BTA.

其他以 Rex Medical, L.P. 為申請人之記錄

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相關器械（代碼：BTA）

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