FDA 510(k)

Ecomed 一次性動脈造影針筒

K 號：K162088 · 2017-01-27

決定日期2017-01-27

產品代碼DXT

諮詢委員會履歷

決定相當於

器材摘要

Ecomed Disposable Angiographic Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Ecomed Solutions, LLC. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K162088. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ecomed Disposable Angiographic Syringes?

Ecomed Disposable Angiographic Syringes is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Ecomed Solutions, LLC. The 510(k) number is K162088.

When did Ecomed Disposable Angiographic Syringes receive FDA 510(k) clearance?

Ecomed Disposable Angiographic Syringes received FDA 510(k) clearance on 2017-01-27, under 510(k) number K162088.

Who is the listed applicant for Ecomed Disposable Angiographic Syringes?

FDA 510(k)記錄將 Ecomed Solutions, LLC 列為申請人。這本身並不足以確立設備製造商。

What is the FDA product code for Ecomed Disposable Angiographic Syringes?

The FDA product code for Ecomed Disposable Angiographic Syringes is DXT.

其他以 Ecomed Solutions, LLC 為申請人之記錄

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。

K254123Ecomed 一次性注射用藥物輸注套件 K234129Ecomed 一次性注射用藥物輸注套件

相關器械（代碼：DXT）

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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官方來源

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