FDA 510(k)

20G x 5/8 Pro-Lock CT Safety Infusion Set

K 號：K171333 · 2017-07-18

申請人Medcomp (Dba Medical Components, Inc.)

決定日期2017-07-18

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

20G x 5/8 Pro-Lock CT Safety Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Dba Medical Components, Inc.). It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K171333. 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 20G x 5/8 Pro-Lock CT Safety Infusion Set?

20G x 5/8 Pro-Lock CT Safety Infusion Set is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Medcomp (Dba Medical Components, Inc.). The 510(k) number is K171333.

When did 20G x 5/8 Pro-Lock CT Safety Infusion Set receive FDA 510(k) clearance?

20G x 5/8 Pro-Lock CT Safety Infusion Set received FDA 510(k) clearance on 2017-07-18, under 510(k) number K171333.

Who is the listed applicant for 20G x 5/8 Pro-Lock CT Safety Infusion Set?

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

What is the FDA product code for 20G x 5/8 Pro-Lock CT Safety Infusion Set?

The FDA product code for 20G x 5/8 Pro-Lock CT Safety Infusion Set is PTI.

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

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相關器械（代碼：PTI）

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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