FDA 510(k)

尊榮雙端口

K 號：K153238 · 2016-03-15

決定日期2016-03-15

產品代碼LJT

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

Dignity Dual Port is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp ( Medical Components). It received FDA 510(k) clearance on 2016-03-15 under 510(k) number K153238. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dignity Dual Port?

Dignity Dual Port is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Medcomp ( Medical Components). The 510(k) number is K153238.

When did Dignity Dual Port receive FDA 510(k) clearance?

Dignity Dual Port received FDA 510(k) clearance on 2016-03-15, under 510(k) number K153238.

Who is the listed applicant for Dignity Dual Port?

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

What is the FDA product code for Dignity Dual Port?

The FDA product code for Dignity Dual Port is LJT.

其他以 Medcomp ( Medical Components) 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。

K162389Medcomp 腔道擴張器

相關器械（代碼：LJT）

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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