FDA 510(k)

nextaro® v, 20/20

K 號：K240748 · 2024-04-16

決定日期2024-04-16

產品代碼LHI

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

nextaro® v, 20/20 is the device name listed in this FDA 510(k) record. The listed applicant is Sfm Medical Devices GmbH. It received FDA 510(k) clearance on 2024-04-16 under 510(k) number K240748. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the nextaro® v, 20/20?

nextaro® v, 20/20 is a medical device that received FDA 510(k) clearance on 2024-04-16. The listed applicant is Sfm Medical Devices GmbH. The 510(k) number is K240748.

When did nextaro® v, 20/20 receive FDA 510(k) clearance?

nextaro® v, 20/20 received FDA 510(k) clearance on 2024-04-16, under 510(k) number K240748.

Who is the listed applicant for nextaro® v, 20/20?

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

What is the FDA product code for nextaro® v, 20/20?

The FDA product code for nextaro® v, 20/20 is LHI.

其他以 Sfm Medical Devices GmbH 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。

K241976nextaro® va, 15mm, 5µm K183187nextaro 轉移系統，nextaro va

相關器械（代碼：LHI）

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。

K252987ADRx® 混合設備Epic Medical Pte. , Ltd.K260301藥劑適配器Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345美林袋式分酒器Medline Industries, LP K251715FlowArt® 輸液針筒進入設備通氣Asset Medikal K251676Medline Microtek C-Flo Bag Decanter, 適用於無菌 (2000S)；Medline Microtek Bag Decanter II，適用於無菌 (2002S)；Medline Microtek Vial Decanter，適用於無菌 (2006S)；Medline Microtek Transfer Device，適用於無菌 (2008S)Microtek Medical, LLC K243404HyHub™ 及 HyHub™ Duo 藥劑針筒進入設備Takeda Pharmaceuticals

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。