FDA 510(k)

健康線CT中線心导管

K 號：K200263 · 2020-03-12

申請人Health Line International Corporation

決定日期2020-03-12

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

Health Line CT Midline Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation. It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K200263. 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 Health Line CT Midline Catheter?

Health Line CT Midline Catheter is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Health Line International Corporation. The 510(k) number is K200263.

When did Health Line CT Midline Catheter receive FDA 510(k) clearance?

Health Line CT Midline Catheter received FDA 510(k) clearance on 2020-03-12, under 510(k) number K200263.

Who is the listed applicant for Health Line CT Midline Catheter?

The FDA 510(k) record lists Health Line International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Health Line CT Midline Catheter?

The FDA product code for Health Line CT Midline Catheter is FOZ.

其他以 Health Line International Corporation 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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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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