FDA 510(k)

Qraypen

K号: K183121 · 2019-07-18

决定日期2019-07-18

产品代码EIA

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决定实质等同

器械摘要

Qraypen is the device name listed in this FDA 510(k) record. The listed applicant is AIOBIO Co., Ltd.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K183121. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Qraypen?

Qraypen is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is AIOBIO Co., Ltd.. The 510(k) number is K183121.

When did Qraypen receive FDA 510(k) clearance?

Qraypen received FDA 510(k) clearance on 2019-07-18, under 510(k) number K183121.

Who is the listed applicant for Qraypen?

The FDA 510(k) record lists AIOBIO Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Qraypen?

The FDA product code for Qraypen is EIA.

列明AIOBIO Co., Ltd.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。

K221275Qraycam PRO

官方来源

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