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FDA 510(k)

TEVADAPTOR 袋適配器 LL，TEVADAPTOR 袋適配器 LL 配 ULTRASITE，TEVADAPTOR 胶囊適配器 SP 配 ULTRASITE，TEVADAPTOR 靜脈輸液次級安全組合配 ULTRASITE，TEVADAPTOR 静脈輸液次級安全組合

K 號：K201142 · 2021-02-25

申請人Simplivia Healthcare , Ltd.
決定日期2021-02-25
產品代碼ONB
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

TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set is the device name listed in this FDA 510(k) record. The listed applicant is Simplivia Healthcare , Ltd.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K201142. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set?

TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Simplivia Healthcare , Ltd.. The 510(k) number is K201142.

When did TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set receive FDA 510(k) clearance?

TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set received FDA 510(k) clearance on 2021-02-25, under 510(k) number K201142.

Who is the listed applicant for TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set?

The FDA 510(k) record lists Simplivia Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set?

The FDA product code for TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set is ONB.

相關臨床試驗

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其他以 Simplivia Healthcare , Ltd. 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。

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相關器械（代碼：ONB）

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。

K251722ProSeal™ 轉移注射器（421120、421130、421140）Epic Medical Pte. , Ltd.K253033Chemfort® 28天 20mm 藥瓶適配器及 13mm 轉換器Simplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima 連接組 (C83-O)；BD PhaSeal™ Optima 尖嘴組 (C180-O)Becton, Dickinson and CompanyK251411Chemfort 女性路氏釘釋針適配器Simplivia Healthcare , Ltd.K251340ProSeal™ 內袋釘針配附加孔 (423370ST, 423370)Epic Medical Pte. , Ltd.K243976ZeroClear™ 袋裝取用器（423100）Epic Medical Pte. , Ltd.

官方來源

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