FDA 510(k)

Medcomp 腔道擴張器

K 號：K162389 · 2017-06-01

決定日期2017-06-01

產品代碼DRE

諮詢委員會履歷

決定相當於

器材摘要

Medcomp Vessel Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp ( Medical Components). It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K162389. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medcomp Vessel Dilator?

Medcomp Vessel Dilator is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Medcomp ( Medical Components). The 510(k) number is K162389.

When did Medcomp Vessel Dilator receive FDA 510(k) clearance?

Medcomp Vessel Dilator received FDA 510(k) clearance on 2017-06-01, under 510(k) number K162389.

Who is the listed applicant for Medcomp Vessel Dilator?

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

What is the FDA product code for Medcomp Vessel Dilator?

The FDA product code for Medcomp Vessel Dilator is DRE.

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

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K153238尊榮雙端口

相關器械（代碼：DRE）

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官方來源

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