FDA 510(k)

Inno-Hydrowire

K 號：K172187 · 2018-04-11

申請人Suzhou Innomed Medical Device Co., Ltd.

決定日期2018-04-11

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

Inno-Hydrowire is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Innomed Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2018-04-11 under 510(k) number K172187. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Inno-Hydrowire?

Inno-Hydrowire is a medical device that received FDA 510(k) clearance on 2018-04-11. The listed applicant is Suzhou Innomed Medical Device Co., Ltd.. The 510(k) number is K172187.

When did Inno-Hydrowire receive FDA 510(k) clearance?

Inno-Hydrowire received FDA 510(k) clearance on 2018-04-11, under 510(k) number K172187.

Who is the listed applicant for Inno-Hydrowire?

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

What is the FDA product code for Inno-Hydrowire?

The FDA product code for Inno-Hydrowire is DQX.

其他以 Suzhou Innomed Medical Device Co., Ltd. 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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