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FDA 510(k)

Amecath 周邊插入中心靜脈針套組

K 號：K152819 · 2016-02-05

申請人Ameco Medical Industries
決定日期2016-02-05
產品代碼LJS
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

Amecath Peripheral inserted Central Venous Catheter Sets is the device name listed in this FDA 510(k) record. The listed applicant is Ameco Medical Industries. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K152819. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Amecath Peripheral inserted Central Venous Catheter Sets?

Amecath Peripheral inserted Central Venous Catheter Sets is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Ameco Medical Industries. The 510(k) number is K152819.

When did Amecath Peripheral inserted Central Venous Catheter Sets receive FDA 510(k) clearance?

Amecath Peripheral inserted Central Venous Catheter Sets received FDA 510(k) clearance on 2016-02-05, under 510(k) number K152819.

Who is the listed applicant for Amecath Peripheral inserted Central Venous Catheter Sets?

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

What is the FDA product code for Amecath Peripheral inserted Central Venous Catheter Sets?

The FDA product code for Amecath Peripheral inserted Central Venous Catheter Sets is LJS.

相關臨床試驗

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相關器械（代碼：LJS）

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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