FDA 510(k)

健康線 CT CVC

K 號：K192533 · 2019-12-10

申請人Health Line International Corporation

決定日期2019-12-10

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 CVC 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 2019-12-10 under 510(k) number K192533. 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 CVC?

Health Line CT CVC is a medical device that received FDA 510(k) clearance on 2019-12-10. The listed applicant is Health Line International Corporation. The 510(k) number is K192533.

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

Health Line CT CVC received FDA 510(k) clearance on 2019-12-10, under 510(k) number K192533.

Who is the listed applicant for Health Line CT CVC?

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 CVC?

The FDA product code for Health Line CT CVC is FOZ.

其他以 Health Line International Corporation 為申請人之記錄

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相關器械（代碼：FOZ）

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