FDA 510(k)

米倫尼姆HX

K 號：K192398 · 2019-10-03

決定日期2019-10-03

產品代碼FIP

諮詢委員會GU

決定相當於

器材摘要

Millenium HX is the device name listed in this FDA 510(k) record. The listed applicant is Mar Cor Purification, Inc.. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K192398. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Millenium HX?

Millenium HX is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Mar Cor Purification, Inc.. The 510(k) number is K192398.

When did Millenium HX receive FDA 510(k) clearance?

Millenium HX received FDA 510(k) clearance on 2019-10-03, under 510(k) number K192398.

Who is the listed applicant for Millenium HX?

The FDA 510(k) record lists Mar Cor Purification, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Millenium HX?

The FDA product code for Millenium HX is FIP.

其他以 Mar Cor Purification, Inc. 為申請人之記錄

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官方來源

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