FDA 510(k)

IV-eye IV眼

K 號：K152088 · 2016-02-24

決定日期2016-02-24

產品代碼KZA

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

IV-eye is the device name listed in this FDA 510(k) record. The listed applicant is Novarix Limited. It received FDA 510(k) clearance on 2016-02-24 under 510(k) number K152088. The device is classified under product code KZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IV-eye?

IV-eye is a medical device that received FDA 510(k) clearance on 2016-02-24. The listed applicant is Novarix Limited. The 510(k) number is K152088.

When did IV-eye receive FDA 510(k) clearance?

IV-eye received FDA 510(k) clearance on 2016-02-24, under 510(k) number K152088.

Who is the listed applicant for IV-eye?

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

What is the FDA product code for IV-eye?

The FDA product code for IV-eye is KZA.

官方來源

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