FDA 510(k)

Optomed Aurora 相机，配备 Aurora 视网膜模块和 Aurora 前部模块

K号: K180378 · 2018-04-05

决定日期2018-04-05

产品代码HKI

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决定实质等同

器械摘要

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module is the device name listed in this FDA 510(k) record. The listed applicant is Optomed OY. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K180378. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module?

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Optomed OY. The 510(k) number is K180378.

When did Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module receive FDA 510(k) clearance?

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module received FDA 510(k) clearance on 2018-04-05, under 510(k) number K180378.

Who is the listed applicant for Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module?

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

What is the FDA product code for Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module?

The FDA product code for Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module is HKI.

列明Optomed OY为申报人的其他记录

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K163021HAAG-STREIT FUNDUS 模块 300

官方来源

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