FDA 510(k)

UNO 30

K 號：K190028 · 2020-01-15

決定日期2020-01-15

產品代碼OMP

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

UNO 30 is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K190028. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UNO 30?

UNO 30 is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Genadyne Biotechnologies. The 510(k) number is K190028.

When did UNO 30 receive FDA 510(k) clearance?

UNO 30 received FDA 510(k) clearance on 2020-01-15, under 510(k) number K190028.

Who is the listed applicant for UNO 30?

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

What is the FDA product code for UNO 30?

The FDA product code for UNO 30 is OMP.

其他以 Genadyne Biotechnologies 為申請人之記錄

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相關器械（代碼：OMP）

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官方來源

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