FDA 510(k)

Elcam 阻斷釘及分配器

K 號：K190489 · 2019-04-23

決定日期2019-04-23

產品代碼FMG

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Elcam Stopcocks and Manifolds is the device name listed in this FDA 510(k) record. The listed applicant is Elcam Medical Acal. It received FDA 510(k) clearance on 2019-04-23 under 510(k) number K190489. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elcam Stopcocks and Manifolds?

Elcam Stopcocks and Manifolds is a medical device that received FDA 510(k) clearance on 2019-04-23. The listed applicant is Elcam Medical Acal. The 510(k) number is K190489.

When did Elcam Stopcocks and Manifolds receive FDA 510(k) clearance?

Elcam Stopcocks and Manifolds received FDA 510(k) clearance on 2019-04-23, under 510(k) number K190489.

Who is the listed applicant for Elcam Stopcocks and Manifolds?

The FDA 510(k) record lists Elcam Medical Acal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elcam Stopcocks and Manifolds?

The FDA product code for Elcam Stopcocks and Manifolds is FMG.

其他以 Elcam Medical Acal 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。

K231900A-TAP（以前稱為Arthrotap）K211204SafePort™ 分流器（或閥門）

相關器械（代碼：FMG）

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。

K242255Qitexio® 4向止回閥 (QIT014)Medex K223499三通截止閥M/S Romsons International K223175內血管輸注設備組合，含閥門和分配器Baxter Healthcare Corporation K211204SafePort™ 分流器（或閥門）Elcam Medical Acal K210516Clicky CrossYomura Technologies, Inc.K190539轉向信號閥門無菌，轉向信號閥門大量無菌，轉向信號閥門帶歧管无菌，轉向信號閥門帶歧管大量無菌Monumedical, LLC

官方來源

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