FDA 510(k)

萊貝-弗拉斯海姆 IBP 轉移組

K 號：K193010 · 2020-11-18

決定日期2020-11-18

產品代碼PQH

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

Liebel-Flarsheim IBP Transfer Set is the device name listed in this FDA 510(k) record. The listed applicant is Liebel-Flarsheim Company, LLC. It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K193010. The device is classified under product code PQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Liebel-Flarsheim IBP Transfer Set?

Liebel-Flarsheim IBP Transfer Set is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is Liebel-Flarsheim Company, LLC. The 510(k) number is K193010.

When did Liebel-Flarsheim IBP Transfer Set receive FDA 510(k) clearance?

Liebel-Flarsheim IBP Transfer Set received FDA 510(k) clearance on 2020-11-18, under 510(k) number K193010.

Who is the listed applicant for Liebel-Flarsheim IBP Transfer Set?

The FDA 510(k) record lists Liebel-Flarsheim Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Liebel-Flarsheim IBP Transfer Set?

The FDA product code for Liebel-Flarsheim IBP Transfer Set is PQH.

其他以 Liebel-Flarsheim Company, LLC 為申請人之記錄

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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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