FDA 510(k)

Osstell 信标

K号: K181888 · 2019-08-22

决定日期2019-08-22

产品代码EKX

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决定实质等同

器械摘要

Osstell Beacon is the device name listed in this FDA 510(k) record. The listed applicant is Osstell AB. It received FDA 510(k) clearance on 2019-08-22 under 510(k) number K181888. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Osstell Beacon?

Osstell Beacon is a medical device that received FDA 510(k) clearance on 2019-08-22. The listed applicant is Osstell AB. The 510(k) number is K181888.

When did Osstell Beacon receive FDA 510(k) clearance?

Osstell Beacon received FDA 510(k) clearance on 2019-08-22, under 510(k) number K181888.

Who is the listed applicant for Osstell Beacon?

FDA 510(k)记录显示Osstell AB为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Osstell Beacon?

The FDA product code for Osstell Beacon is EKX.

列明Osstell AB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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官方来源

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