FDA 510(k)

IV-eye

K号: K152088 · 2016-02-24

决定日期2016-02-24

产品代码KZA

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。