FDA 510(k)

靜脈輔助系統

K 號：K150980 · 2016-05-12

決定日期2016-05-12

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

Venous Assist System is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K150980. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Venous Assist System?

Venous Assist System is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K150980.

When did Venous Assist System receive FDA 510(k) clearance?

Venous Assist System received FDA 510(k) clearance on 2016-05-12, under 510(k) number K150980.

Who is the listed applicant for Venous Assist System?

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

What is the FDA product code for Venous Assist System?

The FDA product code for Venous Assist System is JOW.

其他以 Daesung Maref Co., Ltd. 為申請人之記錄

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相關器械（代碼：JOW）

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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