FDA 510(k)

Endorate 過濾器組

K 號：K181509 · 2018-07-06

決定日期2018-07-06

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

Endorate Valve Sets is the device name listed in this FDA 510(k) record. The listed applicant is Smartdata Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2018-07-06 under 510(k) number K181509. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endorate Valve Sets?

Endorate Valve Sets is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is Smartdata Suzhou Co., Ltd.. The 510(k) number is K181509.

When did Endorate Valve Sets receive FDA 510(k) clearance?

Endorate Valve Sets received FDA 510(k) clearance on 2018-07-06, under 510(k) number K181509.

Who is the listed applicant for Endorate Valve Sets?

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

What is the FDA product code for Endorate Valve Sets?

The FDA product code for Endorate Valve Sets is OCX.

其他以 Smartdata Suzhou Co., Ltd. 為申請人之記錄

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官方來源

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