FDA 510(k)

EPIFLO-28

K 號：K190742 · 2019-12-13

決定日期2019-12-13

產品代碼KPJ

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

EPIFLO-28 is the device name listed in this FDA 510(k) record. The listed applicant is Neogenix, LLC Dba Ogenix. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K190742. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EPIFLO-28?

EPIFLO-28 is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Neogenix, LLC Dba Ogenix. The 510(k) number is K190742.

When did EPIFLO-28 receive FDA 510(k) clearance?

EPIFLO-28 received FDA 510(k) clearance on 2019-12-13, under 510(k) number K190742.

Who is the listed applicant for EPIFLO-28?

The FDA 510(k) record lists Neogenix, LLC Dba Ogenix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPIFLO-28?

The FDA product code for EPIFLO-28 is KPJ.

相關器械（代碼：KPJ）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：KPJ）

官方來源