FDA 510(k)

IV-eye 医薬品機器規制文の翻訳は以下の通りです。 IV-eye

K番号: K152088 · 2016-02-24

決定日2016-02-24

製品コードKZA

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

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.

よくある質問

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.

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