NMI雙端口II
K 號：K151239 · 2016-06-06
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決定日期2016-06-06
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
NMI DUAL PORT II is the device name listed in this FDA 510(k) record. The listed applicant is Navilyst Medical, Inc.. It received FDA 510(k) clearance on 2016-06-06 under 510(k) number K151239. 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 NMI DUAL PORT II?
NMI DUAL PORT II is a medical device that received FDA 510(k) clearance on 2016-06-06. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K151239.
When did NMI DUAL PORT II receive FDA 510(k) clearance?
NMI DUAL PORT II received FDA 510(k) clearance on 2016-06-06, under 510(k) number K151239.
Who is the listed applicant for NMI DUAL PORT II?
The FDA 510(k) record lists Navilyst Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NMI DUAL PORT II?
The FDA product code for NMI DUAL PORT II is LJT.
其他以 Navilyst Medical, Inc. 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。
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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