FDA 510(k)

Pro-Lock CT 安全輸液組

K 號：K162271 · 2017-04-26

決定日期2017-04-26

產品代碼PTI

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

Pro-Lock CT Safety Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Medical Components, Inc.). It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K162271. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pro-Lock CT Safety Infusion Set?

Pro-Lock CT Safety Infusion Set is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Medcomp (Medical Components, Inc.). The 510(k) number is K162271.

When did Pro-Lock CT Safety Infusion Set receive FDA 510(k) clearance?

Pro-Lock CT Safety Infusion Set received FDA 510(k) clearance on 2017-04-26, under 510(k) number K162271.

Who is the listed applicant for Pro-Lock CT Safety Infusion Set?

The FDA 510(k) record lists Medcomp (Medical Components, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pro-Lock CT Safety Infusion Set?

The FDA product code for Pro-Lock CT Safety Infusion Set is PTI.

其他以 Medcomp (Medical Components, Inc.) 為申請人之記錄

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相關器械（代碼：PTI）

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官方來源

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