FDA 510(k)

BD 鋤管 NRFit 鎖定和 BD 鋤管 NRFit 滑動

K 號：K192538 · 2020-09-04

決定日期2020-09-04

產品代碼QEH

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

BD Syringe NRFit Lok and BD Syringe NRFit Slip is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K192538. The device is classified under product code QEH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD Syringe NRFit Lok and BD Syringe NRFit Slip?

BD Syringe NRFit Lok and BD Syringe NRFit Slip is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K192538.

When did BD Syringe NRFit Lok and BD Syringe NRFit Slip receive FDA 510(k) clearance?

BD Syringe NRFit Lok and BD Syringe NRFit Slip received FDA 510(k) clearance on 2020-09-04, under 510(k) number K192538.

Who is the listed applicant for BD Syringe NRFit Lok and BD Syringe NRFit Slip?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Syringe NRFit Lok and BD Syringe NRFit Slip?

The FDA product code for BD Syringe NRFit Lok and BD Syringe NRFit Slip is QEH.

其他以 Becton, Dickinson and Company 為申請人之記錄

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相關器械（代碼：QEH）

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。

K241385Omnifix 靜脈注射針 NRFitB.Braun Medical, Inc.K213800Artiglass NRFitTM Tip L.O.R. 玻璃針筒Artiglass Srl K201031NRFit® 胶囊，男性及女性神經幹針頭蓋International Medical Industries, Inc.K181374NRFit 靜脈注射針Jiangsu Caina Medical Co.,Ltd

官方來源

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