MEDRAD® 影像大量包裝轉移組
K 號：K173913 · 2018-05-04
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決定日期2018-05-04
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
MEDRAD® Imaging Bulk Package Transfer Set is the device name listed in this FDA 510(k) record. The listed applicant is Bayer U.S., LLC. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K173913. 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 MEDRAD® Imaging Bulk Package Transfer Set?
MEDRAD® Imaging Bulk Package Transfer Set is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Bayer U.S., LLC. The 510(k) number is K173913.
When did MEDRAD® Imaging Bulk Package Transfer Set receive FDA 510(k) clearance?
MEDRAD® Imaging Bulk Package Transfer Set received FDA 510(k) clearance on 2018-05-04, under 510(k) number K173913.
Who is the listed applicant for MEDRAD® Imaging Bulk Package Transfer Set?
The FDA 510(k) record lists Bayer U.S., LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MEDRAD® Imaging Bulk Package Transfer Set?
The FDA product code for MEDRAD® Imaging Bulk Package Transfer Set is PQH.
相關臨床試驗
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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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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