FDA 510(k)

046 Zenith Flex

K 號：K190338 · 2019-08-02

決定日期2019-08-02

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

046 Zenith Flex is the device name listed in this FDA 510(k) record. The listed applicant is Inneuroco, Inc.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K190338. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 046 Zenith Flex?

046 Zenith Flex is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Inneuroco, Inc.. The 510(k) number is K190338.

When did 046 Zenith Flex receive FDA 510(k) clearance?

046 Zenith Flex received FDA 510(k) clearance on 2019-08-02, under 510(k) number K190338.

Who is the listed applicant for 046 Zenith Flex?

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

What is the FDA product code for 046 Zenith Flex?

The FDA product code for 046 Zenith Flex is NRY.

其他以 Inneuroco, Inc. 為申請人之記錄

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相關器械（代碼：NRY）

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