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FDA 510(k)

Vial2Bag 高級® 13mm 混合設備

K 號：K230988 · 2023-12-01

申請人West Pharma. Services IL, Ltd.
決定日期2023-12-01
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

Vial2Bag Advanced® 13mm Admixture Device is the device name listed in this FDA 510(k) record. The listed applicant is West Pharma. Services IL, Ltd.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K230988. 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 Vial2Bag Advanced® 13mm Admixture Device?

Vial2Bag Advanced® 13mm Admixture Device is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is West Pharma. Services IL, Ltd.. The 510(k) number is K230988.

When did Vial2Bag Advanced® 13mm Admixture Device receive FDA 510(k) clearance?

Vial2Bag Advanced® 13mm Admixture Device received FDA 510(k) clearance on 2023-12-01, under 510(k) number K230988.

Who is the listed applicant for Vial2Bag Advanced® 13mm Admixture Device?

The FDA 510(k) record lists West Pharma. Services IL, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial2Bag Advanced® 13mm Admixture Device?

The FDA product code for Vial2Bag Advanced® 13mm Admixture Device is LHI.

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其他以 West Pharma. Services IL, 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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官方來源

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