FDA 510(k)

BD 急性中心靜脈管

K 號：K190855 · 2019-11-01

申請人Bard Access Systems, Inc. (Bard Has Joined Bd)

決定日期2019-11-01

產品代碼FOZ

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

BD Acute Central Line is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K190855. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD Acute Central Line?

BD Acute Central Line is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). The 510(k) number is K190855.

When did BD Acute Central Line receive FDA 510(k) clearance?

BD Acute Central Line received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190855.

Who is the listed applicant for BD Acute Central Line?

The FDA 510(k) record lists Bard Access Systems, Inc. (Bard Has Joined Bd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Acute Central Line?

The FDA product code for BD Acute Central Line is FOZ.

其他以 Bard Access Systems, Inc. (Bard Has Joined Bd) 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。

K200266BD Centro Vena 急性中心靜脈管 (7 法寸雙腔)

相關器械（代碼：FOZ）

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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