FDA 510(k)

TEVADAPTOR 關閉藥物重組及轉移系統

K 號：K180489 · 2018-09-21

決定日期2018-09-21

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 Closed Drug Reconstitution and Transfer System is the device name listed in this FDA 510(k) record. The listed applicant is Teva Medical Ltd., Migada Plant. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K180489. 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 Closed Drug Reconstitution and Transfer System?

TEVADAPTOR Closed Drug Reconstitution and Transfer System is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Teva Medical Ltd., Migada Plant. The 510(k) number is K180489.

When did TEVADAPTOR Closed Drug Reconstitution and Transfer System receive FDA 510(k) clearance?

TEVADAPTOR Closed Drug Reconstitution and Transfer System received FDA 510(k) clearance on 2018-09-21, under 510(k) number K180489.

Who is the listed applicant for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

The FDA 510(k) record lists Teva Medical Ltd., Migada Plant as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

The FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System is ONB.

其他以 Teva Medical Ltd., Migada Plant 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。

K170680TEVADAPTOR 關閉藥物重組及轉移系統

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。

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官方來源

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