FDA 510(k)

Orion

K号: K200529 · 2020-08-12

决定日期2020-08-12

产品代码LXV

决定实质等同

器械摘要

Orion is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics A/S. It received FDA 510(k) clearance on 2020-08-12 under 510(k) number K200529. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

常见问题

What is the Orion?

Orion is a medical device that received FDA 510(k) clearance on 2020-08-12. The listed applicant is Interacoustics A/S. The 510(k) number is K200529.

When did Orion receive FDA 510(k) clearance?

Orion received FDA 510(k) clearance on 2020-08-12, under 510(k) number K200529.

Who is the listed applicant for Orion?

The FDA 510(k) record lists Interacoustics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orion?

The FDA product code for Orion is LXV.

列明Interacoustics A/S为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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