FDA 510(k)

烏爾里希傳輸設備

K 號：K161723 · 2016-12-21

決定日期2016-12-21

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

ulrich Transfer Set is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K161723. 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 ulrich Transfer Set?

ulrich Transfer Set is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K161723.

When did ulrich Transfer Set receive FDA 510(k) clearance?

ulrich Transfer Set received FDA 510(k) clearance on 2016-12-21, under 510(k) number K161723.

Who is the listed applicant for ulrich Transfer Set?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ulrich Transfer Set?

The FDA product code for ulrich Transfer Set is PQH.

其他以 Ulrich GmbH & Co. KG 為申請人之記錄

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相關器械（代碼：PQH）

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。

K253688MEDRAD® 影像大量包裝轉移針Bayer Medical Care, Inc.K193010萊貝-弗拉斯海姆 IBP 轉移組Liebel-Flarsheim Company, LLC K200280醫療設備規範文本翻譯： MEDRAD影像大量包裝轉移針Bayer Medical Care, Inc.K173913MEDRAD® 影像大量包裝轉移組Bayer U.S., LLC

官方來源

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